NCT01939158 is a Phase 3 clinical trial of Meningococcal vaccine GSK134612 in Infections, Meningococcal, sponsored by Pfizer.

Who is sponsoring NCT01939158?

NCT01939158 is sponsored by Pfizer.

What drugs are being tested in NCT01939158?

Interventions in NCT01939158: Meningococcal vaccine GSK134612, Prevenar 13™.

What condition does NCT01939158 study?

NCT01939158 studies Infections, Meningococcal.

Is NCT01939158 still recruiting?

NCT01939158 is currently completed. Last updated 5 October 2021.

Are results published for NCT01939158?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-05 · How we verify

NCT01939158

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

Completed Phase 3 Results posted Last updated 5 October 2021

What this trial tests

Phase 3 trial testing Meningococcal vaccine GSK134612 in Infections, Meningococcal in 803 participants. Completed in 5 December 2019.

Timeline

2 October 2013

Primary endpoint
5 December 2019

5 December 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	803
Start date	2 October 2013
Primary completion	5 December 2019
Estimated completion	5 December 2019
Sites	51 locations across Panama, South Africa, Canada, Australia, Turkey (Türkiye), Czechia

Drugs / interventions tested

Meningococcal vaccine GSK134612 — full drug profile →
Prevenar 13™

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

Pfizer — full company profile →

Who can join

Adults 12 Months to 14 Months, any sex, with Infections, Meningococcal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups Primary · 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and

rSBA-MenA

Group	Value	95% CI
ACWY1d Group	97.8	94.4 – 99.4
ACWY2d Group	96.8	92.8 – 99.0
Co-ad Group	94.9	90.6 – 97.7

rSBA-MenC

Group	Value	95% CI
ACWY1d Group	95.0	90.7 – 97.7
ACWY2d Group	95.5	91.0 – 98.2
Co-ad Group	96.0	92.0 – 98.4

rSBA-MenW-135

Group	Value	95% CI
ACWY1d Group	95.0	90.7 – 97.7
ACWY2d Group	94.9	90.3 – 97.8
Co-ad Group	93.2	88.5 – 96.4

rSBA-MenY

Group	Value	95% CI
ACWY1d Group	92.8	88.0 – 96.1
ACWY2d Group	93.6	88.6 – 96.9
Co-ad Group	89.8	84.4 – 93.9

Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group Primary · 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did n

rSBA-MenA

Group	Value	95% CI
ACWY2d Group	98.0	94.3 – 99.6

rSBA-MenC

Group	Value	95% CI
ACWY2d Group	98.7	95.3 – 99.8

rSBA-MenW-135

Group	Value	95% CI
ACWY2d Group	100.0	97.6 – 100.0

rSBA-MenY

Group	Value	95% CI
ACWY2d Group	99.3	96.3 – 100.0

Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups Primary · At Year 1

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did

rSBA-MenA: >=1:8

Group	Value	95% CI
ACWY1d Group	63.5	55.7 – 70.8
ACWY2d Group	70.6	62.4 – 77.9

rSBA-MenC: >=1:8

Group	Value	95% CI
ACWY1d Group	49.1	41.3 – 56.9
ACWY2d Group	55.2	46.7 – 63.6

rSBA-MenW-135: >=1:8

Group	Value	95% CI
ACWY1d Group	65.3	57.5 – 72.5
ACWY2d Group	77.6	69.9 – 84.2

rSBA-MenY: >=1:8

Group	Value	95% CI
ACWY1d Group	73.1	65.7 – 79.6
ACWY2d Group	79.7	72.2 – 86.0

rSBA-MenA: >=1:128

Group	Value	95% CI
ACWY1d Group	44.9	37.2 – 52.8
ACWY2d Group	50.3	41.9 – 58.8

rSBA-MenC: >=1:128

Group	Value	95% CI
ACWY1d Group	21.0	15.1 – 27.9
ACWY2d Group	27.3	20.2 – 35.3

rSBA-MenW-135: >=1:128

Group	Value	95% CI
ACWY1d Group	46.7	39.0 – 54.6
ACWY2d Group	60.1	51.6 – 68.2

rSBA-MenY: >=1:128

Group	Value	95% CI
ACWY1d Group	52.1	44.2 – 59.9
ACWY2d Group	60.8	52.3 – 68.9

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups Primary · At Year 1

Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical

rSBA-MenA

Group	Value	95% CI
ACWY1d Group	62.7	42.6 – 92.2
ACWY2d Group	76.6	50.7 – 115.7

rSBA-MenC

Group	Value	95% CI
ACWY1d Group	16.2	12.4 – 21.1
ACWY2d Group	21.2	15.6 – 28.9

rSBA-MenW-135

Group	Value	95% CI
ACWY1d Group	57.2	39.9 – 82.0
ACWY2d Group	123.1	82.7 – 183.4

rSBA-MenY

Group	Value	95% CI
ACWY1d Group	76.8	54.2 – 109.0
ACWY2d Group	112.3	77.5 – 162.8

Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups Primary · At Year 3

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did

rSBA-MenA: >=1:8

Group	Value	95% CI
ACWY1d Group	46.9	38.7 – 55.3
ACWY2d Group	54.5	45.2 – 63.6

rSBA-MenC: >=1:8

Group	Value	95% CI
ACWY1d Group	35.4	27.7 – 43.7
ACWY2d Group	33.9	25.5 – 43.0

rSBA-MenW-135: >=1:8

Group	Value	95% CI
ACWY1d Group	59.2	50.8 – 67.2
ACWY2d Group	72.7	63.9 – 80.4

rSBA-MenY: >=1:8

Group	Value	95% CI
ACWY1d Group	61.9	53.5 – 69.8
ACWY2d Group	68.6	59.5 – 76.7

rSBA-MenA: >=1:128

Group	Value	95% CI
ACWY1d Group	34.0	26.4 – 42.3
ACWY2d Group	31.4	23.3 – 40.5

rSBA-MenC: >=1:128

Group	Value	95% CI
ACWY1d Group	9.5	5.3 – 15.5
ACWY2d Group	15.7	9.7 – 23.4

rSBA-MenW-135: >=1:128

Group	Value	95% CI
ACWY1d Group	42.9	34.7 – 51.3
ACWY2d Group	52.9	43.6 – 62.0

rSBA-MenY: >=1:128

Group	Value	95% CI
ACWY1d Group	49.0	40.7 – 57.3
ACWY2d Group	53.7	44.4 – 62.8

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups Primary · At Year 3

Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical

rSBA-MenA

Group	Value	95% CI
ACWY1d Group	29.7	19.8 – 44.5
ACWY2d Group	28.5	18.7 – 43.6

rSBA-MenC

Group	Value	95% CI
ACWY1d Group	9.8	7.6 – 12.7
ACWY2d Group	11.5	8.4 – 15.8

rSBA-MenW-135

Group	Value	95% CI
ACWY1d Group	42.5	29.2 – 61.8
ACWY2d Group	92.9	59.9 – 143.9

rSBA-MenY

Group	Value	95% CI
ACWY1d Group	58.0	39.1 – 86.0
ACWY2d Group	75.1	48.7 – 115.9

Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups Primary · At Year 5

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did

rSBA-MenA: >=1:8

Group	Value	95% CI
ACWY1d Group	58.6	49.8 – 67.1
ACWY2d Group	65.8	56.5 – 74.3

rSBA-MenC: >=1:8

Group	Value	95% CI
ACWY1d Group	20.5	13.9 – 28.3
ACWY2d Group	28.4	20.5 – 37.6

rSBA-MenW-135: >=1:8

Group	Value	95% CI
ACWY1d Group	44.4	35.8 – 53.2
ACWY2d Group	50.4	41.0 – 59.8

rSBA-MenY: >=1:8

Group	Value	95% CI
ACWY1d Group	47.4	38.7 – 56.2
ACWY2d Group	58.1	48.6 – 67.2

rSBA-MenA: >=1:128

Group	Value	95% CI
ACWY1d Group	43.6	35.0 – 52.5
ACWY2d Group	53.0	43.5 – 62.3

rSBA-MenC: >=1:128

Group	Value	95% CI
ACWY1d Group	6.1	2.7 – 11.6
ACWY2d Group	10.3	5.5 – 17.4

rSBA-MenW-135: >=1:128

Group	Value	95% CI
ACWY1d Group	32.3	24.5 – 41.0
ACWY2d Group	39.3	30.4 – 48.8

rSBA-MenY: >=1:128

Group	Value	95% CI
ACWY1d Group	39.8	31.5 – 48.7
ACWY2d Group	52.1	42.7 – 61.5

Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups Primary · At Year 5

Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical

rSBA-MenA

Group	Value	95% CI
ACWY1d Group	46.8	30.7 – 71.5
ACWY2d Group	69.9	44.7 – 109.3

rSBA-MenC

Group	Value	95% CI
ACWY1d Group	6.6	5.3 – 8.2
ACWY2d Group	8.5	6.4 – 11.2

rSBA-MenW-135

Group	Value	95% CI
ACWY1d Group	25.0	16.7 – 37.6
ACWY2d Group	37.1	23.3 – 59.0

rSBA-MenY

Group	Value	95% CI
ACWY1d Group	36.5	23.6 – 56.2
ACWY2d Group	55.8	35.7 – 87.5

Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups Primary · 1 month after administration of Prevnar 13 (i.e. at Month 1)

GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2

anti-1

Group	Value	95% CI
Co-ad Group	2.94	2.56 – 3.36
PCV13 Group	2.62	2.27 – 3.01

anti-3

Group	Value	95% CI
Co-ad Group	0.80	0.69 – 0.91
PCV13 Group	0.71	0.62 – 0.81

anti-4

Group	Value	95% CI
Co-ad Group	2.46	2.14 – 2.83
PCV13 Group	1.96	1.69 – 2.26

anti-5

Group	Value	95% CI
Co-ad Group	2.09	1.84 – 2.37
PCV13 Group	1.67	1.46 – 1.91

anti-6A

Group	Value	95% CI
Co-ad Group	8.59	7.50 – 9.85
PCV13 Group	7.28	6.33 – 8.37

anti-6B

Group	Value	95% CI
Co-ad Group	7.36	6.33 – 8.55
PCV13 Group	6.68	5.70 – 7.83

anti-7F

Group	Value	95% CI
Co-ad Group	5.14	4.49 – 5.88
PCV13 Group	4.81	4.23 – 5.47

anti-9V

Group	Value	95% CI
Co-ad Group	2.03	1.78 – 2.30
PCV13 Group	1.79	1.59 – 2.03

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups Secondary · 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \>=1:4 and \>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did n

hSBA-MenA: >=1:4

Group	Value	95% CI
ACWY1d Group	95.9	88.6 – 99.2
ACWY2d Group	97.0	89.5 – 99.6

hSBA-MenC: >=1:4

Group	Value	95% CI
ACWY1d Group	98.7	93.1 – 100.0
ACWY2d Group	97.1	90.1 – 99.7

hSBA-MenW-135: >=1:4

Group	Value	95% CI
ACWY1d Group	62.5	50.3 – 73.6
ACWY2d Group	68.9	55.7 – 80.1

hSBA-MenY: >=1:4

Group	Value	95% CI
ACWY1d Group	67.6	55.5 – 78.2
ACWY2d Group	64.3	50.4 – 76.6

hSBA-MenA: >=1:8

Group	Value	95% CI
ACWY1d Group	95.9	88.6 – 99.2
ACWY2d Group	97.0	89.5 – 99.6

hSBA-MenC: >=1:8

Group	Value	95% CI
ACWY1d Group	98.7	93.1 – 100.0
ACWY2d Group	95.7	88.0 – 99.1

hSBA-MenW-135: >=1:8

Group	Value	95% CI
ACWY1d Group	62.5	50.3 – 73.6
ACWY2d Group	68.9	55.7 – 80.1

hSBA-MenY: >=1:8

Group	Value	95% CI
ACWY1d Group	67.6	55.5 – 78.2
ACWY2d Group	64.3	50.4 – 76.6

Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group Secondary · 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \>=1:4 and \>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in prot

hSBA-MenA: >=1:4

Group	Value	95% CI
ACWY2d Group	97.0	89.5 – 99.6

hSBA-MenC: >=1:4

Group	Value	95% CI
ACWY2d Group	100.0	94.8 – 100.0

hSBA-MenW-135: >=1:4

Group	Value	95% CI
ACWY2d Group	97.1	90.1 – 99.7

hSBA-MenY: >=1:4

Group	Value	95% CI
ACWY2d Group	95.3	86.9 – 99.0

hSBA-MenA: >=1:8

Group	Value	95% CI
ACWY2d Group	97.0	89.5 – 99.6

hSBA-MenC: >=1:8

Group	Value	95% CI
ACWY2d Group	100.0	94.8 – 100.0

hSBA-MenW-135: >=1:8

Group	Value	95% CI
ACWY2d Group	97.1	90.1 – 99.7

hSBA-MenY: >=1:8

Group	Value	95% CI
ACWY2d Group	95.3	86.9 – 99.0

Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups Secondary · 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical

hSBA-MenA

Group	Value	95% CI
ACWY1d Group	118.0	86.8 – 160.5
ACWY2d Group	132.9	98.1 – 180.1

hSBA-MenC

Group	Value	95% CI
ACWY1d Group	151.9	104.8 – 220.4
ACWY2d Group	160.8	109.8 – 235.5

hSBA-MenW-135

Group	Value	95% CI
ACWY1d Group	27.5	16.1 – 46.8
ACWY2d Group	26.2	16.0 – 43.0

hSBA-MenY

Group	Value	95% CI
ACWY1d Group	41.2	23.7 – 71.5
ACWY2d Group	31.9	17.6 – 57.9

Adverse events — posted to ClinicalTrials.gov

Time frame: AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ACWY1d Group

Serious: 12/203 (6%)

Deaths: 0/203

ACWY2d Group

Serious: 11/197 (6%)

Deaths: 0/197

Co-ad Group

Serious: 13/201 (6%)

Deaths: 1/201

PCV13 Group

Serious: 16/201 (8%)

Deaths: 1/201

Serious adverse events (46 terms)

Reaction	System	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Pneumonia	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Anaphylactic shock	Immune system disorders	—	—	—	—
Abscess limb	Infections and infestations	—	—	—	—
Bronchitis viral	Infections and infestations	—	—	—	—
Croup infectious	Infections and infestations	—	—	—	—
Encephalitis	Infections and infestations	—	—	—	—
Gastroenteritis rotavirus	Infections and infestations	—	—	—	—
Gastroenteritis salmonella	Infections and infestations	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—
Meningitis aseptic	Infections and infestations	—	—	—	—
Myringitis	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Pneumonia pneumococcal	Infections and infestations	—	—	—	—

Other adverse events (153 terms — click to expand)

Reaction	System	ACWY1d Group	ACWY2d Group	Co-ad Group	PCV13 Group
Irritability/Fussiness	General disorders	—	—	—	—
Redness	General disorders	—	—	—	—
Drowsiness	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Loss Of Appetite	General disorders	—	—	—	—
Swelling	General disorders	—	—	—	—
Temperature/(Rectal) (°C)	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Teething	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Hand-foot-and-mouth disease	Infections and infestations	—	—	—	—
Irritability	Psychiatric disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Varicella	Infections and infestations	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Croup infectious	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Febrile convulsion	Nervous system disorders	—	—	—	—
Sleep disorder	Psychiatric disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Influenza like illness	General disorders	—	—	—	—

Most-reported serious reactions: Pneumonia, Upper respiratory tract infection, Bronchiolitis, Bronchitis, Gastroenteritis, Tonsillitis, Bronchospasm, Iron deficiency anaemia.

Data from ClinicalTrials.gov NCT01939158 adverse events section.

Sponsor's own description

The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Epidemiologic Trends, Global Shifts in Meningococcal Vaccination Guidelines, and Data Supporting the Use of MenACWY-TT Vaccine: A Review.
Presa J, Findlow J, Vojicic J, Williams S, et al · · 2019 · cited 34× · PMID 31347097 · DOI 10.1007/s40121-019-0254-1
Immunogenicity and safety of one or two doses of the quadrivalent meningococcal vaccine MenACWY-TT given alone or with the 13-valent pneumococcal conjugate vaccine in toddlers: A phase III, open-label, randomised study.
Cutland CL, Nolan T, Halperin SA, Kurugol Z, et al · · 2018 · cited 13× · PMID 29503112 · DOI 10.1016/j.vaccine.2018.02.013
A phase 3, randomized, controlled, open-label study to evaluate the persistence up to 5 years of 1 or 2 doses of meningococcal conjugate vaccine MenACWY-TT given with or without 13-valent pneumococcal conjugate vaccine in 12-14-month-old children.
Cutland CL, Peyrani P, Webber C, Newton R, et al · · 2023 · cited 4× · PMID 36621408 · DOI 10.1016/j.vaccine.2022.11.048

Verify or expand the search:

Other trials of Meningococcal vaccine GSK134612

Trials testing the same drug.

NCT01755689 — Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administr · Phase 3 · completed
NCT01767376 — Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When C · Phase 3 · completed
NCT01641042 — Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subje · Phase 3 · completed
NCT00955682 — Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612 · Phase 3 · completed
NCT00758264 — Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration · Phase 3 · completed

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01939158 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 5 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01939158.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01939158

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (46 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Meningococcal vaccine GSK134612

Other Pfizer trials

Verify against primary sources