NCT03512288 is a Phase 2 clinical trial of Multivalent in Pneumococcal Infections, sponsored by Pfizer.

Who is sponsoring NCT03512288?

NCT03512288 is sponsored by Pfizer.

What drugs are being tested in NCT03512288?

Interventions in NCT03512288: Multivalent, 13vPnC.

What condition does NCT03512288 study?

NCT03512288 studies Pneumococcal Infections.

Is NCT03512288 still recruiting?

NCT03512288 is currently completed. Last updated 2 March 2021.

Are results published for NCT03512288?

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

Last reviewed 2021-03-02 · How we verify

NCT03512288

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

Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

Completed Phase 2 Results posted Last updated 2 March 2021

What this trial tests

Phase 2 trial testing Multivalent in Pneumococcal Infections in 460 participants. Completed in 11 February 2020.

Timeline

16 April 2018

Primary endpoint
11 February 2020

11 February 2020

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	460
Start date	16 April 2018
Primary completion	11 February 2020
Estimated completion	11 February 2020
Sites	39 locations across United States

Drugs / interventions tested

Multivalent — full drug profile →
13vPnC (13vpnc) — full drug profile →

Conditions studied

Pneumococcal Infections — all drugs for Pneumococcal Infections →

Sponsor

Pfizer — full company profile →

Who can join

Adults 42 Days to 98 Days, any sex, with Pneumococcal Infections. 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 Local Reactions Within 7 Days After Vaccination 1 Primary · Within 7 days after Vaccination 1

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb m

Redness: Any

Group	Value	95% CI
20vPnC	24.9	19.4 – 31.0
13vPnC	25.4	19.9 – 31.7

Redness: Mild

Group	Value	95% CI
20vPnC	22.3	17.1 – 28.2
13vPnC	23.7	18.3 – 29.8

Redness: Moderate

Group	Value	95% CI
20vPnC	2.6	1.0 – 5.6
13vPnC	1.8	0.5 – 4.5

Redness: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 1.6
13vPnC	0	0.0 – 1.6

Swelling: Any

Group	Value	95% CI
20vPnC	12.7	8.6 – 17.7
13vPnC	14.3	10.0 – 19.6

Swelling: Mild

Group	Value	95% CI
20vPnC	10.0	6.5 – 14.7
13vPnC	12.9	8.8 – 18.1

Swelling: Moderate

Group	Value	95% CI
20vPnC	2.2	0.7 – 5.0
13vPnC	1.3	0.3 – 3.9

Swelling: Severe

Group	Value	95% CI
20vPnC	0.4	0.0 – 2.4
13vPnC	0	0.0 – 1.6

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Primary · Within 7 days after Vaccination 2

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Redness: Any

Group	Value	95% CI
20vPnC	24.7	19.0 – 31.0
13vPnC	28.4	22.4 – 35.2

Redness: Mild

Group	Value	95% CI
20vPnC	21.9	16.5 – 28.0
13vPnC	24.0	18.3 – 30.5

Redness: Moderate

Group	Value	95% CI
20vPnC	2.8	1.0 – 6.0
13vPnC	4.4	2.0 – 8.20

Redness: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 1.7
13vPnC	0	0.0 – 1.8

Swelling: Any

Group	Value	95% CI
20vPnC	16.3	11.6 – 21.9
13vPnC	18.6	13.5 – 24.7

Swelling: Mild

Group	Value	95% CI
20vPnC	12.6	8.4 – 17.7
13vPnC	13.2	8.9 – 18.7

Swelling: Moderate

Group	Value	95% CI
20vPnC	3.7	1.6 – 7.2
13vPnC	5.4	2.7 – 9.4

Swelling: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 1.7
13vPnC	0	0.0 – 1.8

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 Primary · Within 7 days after Vaccination 3

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Redness: Any

Group	Value	95% CI
20vPnC	26.9	20.9 – 33.6
13vPnC	26.5	20.6 – 33.1

Redness: Mild

Group	Value	95% CI
20vPnC	26.4	20.4 – 33.0
13vPnC	23.0	17.4 – 29.4

Redness: Moderate

Group	Value	95% CI
20vPnC	0.5	0.0 – 2.7
13vPnC	3.4	1.4 – 6.9

Redness: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 1.8
13vPnC	0	0.0 – 1.8

Swelling: Any

Group	Value	95% CI
20vPnC	17.9	12.9 – 23.9
13vPnC	19.6	14.4 – 25.7

Swelling: Mild

Group	Value	95% CI
20vPnC	16.9	12.0 – 22.8
13vPnC	15.7	11.0 – 21.4

Swelling: Moderate

Group	Value	95% CI
20vPnC	1.0	0.1 – 3.5
13vPnC	3.4	1.4 – 6.9

Swelling: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 1.8
13vPnC	0.5	0.0 – 2.7

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 Primary · Within 7 days after Vaccination 4

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Redness: Any

Group	Value	95% CI
20vPnC	25.8	19.7 – 32.7
13vPnC	30.3	23.7 – 37.4

Redness: Mild

Group	Value	95% CI
20vPnC	24.2	18.2 – 31.0
13vPnC	25.4	19.3 – 32.3

Redness: Moderate

Group	Value	95% CI
20vPnC	1.6	0.3 – 4.6
13vPnC	4.9	2.2 – 9.0

Redness: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 2.0
13vPnC	0	0.0 – 2.0

Swelling: Any

Group	Value	95% CI
20vPnC	17.2	12.1 – 23.4
13vPnC	14.1	9.4 – 19.9

Swelling: Mild

Group	Value	95% CI
20vPnC	15.1	10.2 – 21.0
13vPnC	12.4	8.0 – 18.1

Swelling: Moderate

Group	Value	95% CI
20vPnC	2.2	0.6 – 5.4
13vPnC	1.6	0.3 – 4.7

Swelling: Severe

Group	Value	95% CI
20vPnC	0	0.0 – 2.0
13vPnC	0	0.0 – 2.0

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Primary · Within 7 days after Vaccination 1

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled

Fever: >=38.0 degree C

Group	Value	95% CI
20vPnC	14.4	10.1 – 19.6
13vPnC	9.8	6.3 – 14.5

Fever: >=38.0 degree C to 38.4 degree C

Group	Value	95% CI
20vPnC	10.0	6.5 – 14.7
13vPnC	6.3	3.5 – 10.3

Fever: >38.4 degree C to 38.9 degree C

Group	Value	95% CI
20vPnC	3.9	1.8 – 7.3
13vPnC	2.2	0.7 – 5.1

Fever: >38.9 degree C to 40.0 degree C

Group	Value	95% CI
20vPnC	0.4	0.0 – 2.4
13vPnC	1.3	0.3 – 3.9

Fever: >40.0 degree C

Group	Value	95% CI
20vPnC	0	0.0 – 1.6
13vPnC	0	0.0 – 1.6

Decreased appetite: Any

Group	Value	95% CI
20vPnC	25.3	19.8 – 31.5
13vPnC	30.4	24.4 – 36.8

Decreased appetite: Mild

Group	Value	95% CI
20vPnC	16.2	11.6 – 21.6
13vPnC	19.2	14.3 – 25.0

Decreased appetite: Moderate

Group	Value	95% CI
20vPnC	9.2	5.8 – 13.7
13vPnC	10.7	7.0 – 15.5

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Primary · Within 7 days after Vaccination 2

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual d

Fever: >=38.0 degree C

Group	Value	95% CI
20vPnC	17.2	12.4 – 22.9
13vPnC	23.0	17.4 – 29.4

Fever: >=38.0 degree C to 38.4 degree C

Group	Value	95% CI
20vPnC	10.2	6.5 – 15.1
13vPnC	12.7	8.5 – 18.1

Fever: >38.4 degree C to 38.9 degree C

Group	Value	95% CI
20vPnC	4.2	1.9 – 7.8
13vPnC	7.8	4.5 – 12.4

Fever: >38.9 degree C to 40.0 degree C

Group	Value	95% CI
20vPnC	2.8	1.0 – 6.0
13vPnC	2.5	0.8 – 5.6

Fever: >40.0 degree C

Group	Value	95% CI
20vPnC	0	0.0 – 1.7
13vPnC	0	0.0 – 1.8

Decreased appetite: Any

Group	Value	95% CI
20vPnC	23.3	17.8 – 29.5
13vPnC	27.0	21.0 – 33.6

Decreased appetite: Mild

Group	Value	95% CI
20vPnC	14.4	10.0 – 19.8
13vPnC	14.7	10.1 – 20.3

Decreased appetite: Moderate

Group	Value	95% CI
20vPnC	7.9	4.7 – 12.4
13vPnC	11.8	7.7 – 17.0

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 Primary · Within 7 days after Vaccination 3

Fever: >=38.0 degree C

Group	Value	95% CI
20vPnC	17.9	12.9 – 23.9
13vPnC	18.1	13.1 – 24.1

Fever: >=38.0 degree C to 38.4 degree C

Group	Value	95% CI
20vPnC	10.0	6.2 – 14.9
13vPnC	9.8	6.1 – 14.7

Fever: >38.4 degree C to 38.9 degree C

Group	Value	95% CI
20vPnC	4.5	2.1 – 8.3
13vPnC	4.9	2.4 – 8.8

Fever: >38.9 degree C to 40.0 degree C

Group	Value	95% CI
20vPnC	3.5	1.4 – 7.0
13vPnC	3.4	1.4 – 6.9

Fever: >40.0 degree C

Group	Value	95% CI
20vPnC	0	0.0 – 1.8
13vPnC	0	0.0 – 1.8

Decreased appetite: Any

Group	Value	95% CI
20vPnC	30.8	24.5 – 37.7
13vPnC	33.3	26.9 – 40.3

Decreased appetite: Mild

Group	Value	95% CI
20vPnC	20.9	15.5 – 27.2
13vPnC	19.1	14.0 – 25.2

Decreased appetite: Moderate

Group	Value	95% CI
20vPnC	9.5	5.8 – 14.4
13vPnC	13.7	9.3 – 19.2

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 Primary · Within 7 days after Vaccination 4

Fever: >=38.0 degree C

Group	Value	95% CI
20vPnC	12.4	8.0 – 18.0
13vPnC	14.6	9.8 – 20.5

Fever: >=38.0 degree C to 38.4 degree C

Group	Value	95% CI
20vPnC	5.9	3.0 – 10.3
13vPnC	4.3	1.9 – 8.3

Fever: >38.4 degree C to 38.9 degree C

Group	Value	95% CI
20vPnC	3.2	1.2 – 6.9
13vPnC	7.0	3.8 – 11.7

Fever: >38.9 degree C to 40.0 degree C

Group	Value	95% CI
20vPnC	3.2	1.2 – 6.9
13vPnC	3.2	1.2 – 6.9

Fever: >40.0 degree C

Group	Value	95% CI
20vPnC	0	0.0 – 2.0
13vPnC	0	0.0 – 2.0

Decreased appetite: Any

Group	Value	95% CI
20vPnC	23.7	17.7 – 30.4
13vPnC	29.2	22.8 – 36.3

Decreased appetite: Mild

Group	Value	95% CI
20vPnC	13.4	8.9 – 19.2
13vPnC	15.7	10.8 – 21.7

Decreased appetite: Moderate

Group	Value	95% CI
20vPnC	10.2	6.3 – 15.5
13vPnC	13.5	8.9 – 19.3

Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 Primary · From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.

Group	Value	95% CI
20vPnC	61.0	54.4 – 67.4
13vPnC	56.4	49.7 – 62.9

Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 Primary · From Vaccination 4 to 1 month after Vaccination 4

An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.

Group	Value	95% CI
20vPnC	18.3	13.1 – 24.4
13vPnC	25.3	19.3 – 32.0

Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 Primary · From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)

An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.

Group	Value	95% CI
20vPnC	5.2	2.7 – 8.9
13vPnC	2.2	0.7 – 5.1

Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 Primary · From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)

An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

Group	Value	95% CI
20vPnC	5.2	2.7 – 8.9
13vPnC	3.5	1.5 – 6.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

20vPnC

Serious: 12/231 (5%)

Deaths: 0/231

13vPnC

Serious: 5/227 (2%)

Deaths: 0/227

Serious adverse events (18 terms)

Reaction	System	20vPnC	13vPnC
Anaemia	Blood and lymphatic system disorders	—	—
Bronchiolitis	Infections and infestations	—	—
Bronchitis viral	Infections and infestations	—	—
Croup infectious	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Meningitis viral	Infections and infestations	—	—
Parainfluenzae virus infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Respiratory syncytial virus bronchiolitis	Infections and infestations	—	—
Respiratory syncytial virus infection	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—
Malnutrition	Metabolism and nutrition disorders	—	—
Seizure like phenomena	Nervous system disorders	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—
Oliguria	Renal and urinary disorders	—	—

Other adverse events (55 terms — click to expand)

Reaction	System	20vPnC	13vPnC
Irritability (IRRITABILITY)	Psychiatric disorders	—	—
Hypersomnia (INCREASED SLEEP)	Nervous system disorders	—	—
Injection site pain (PAIN)	General disorders	—	—
Decreased appetite (DECREASED APPETITE)	Metabolism and nutrition disorders	—	—
Injection site erythema (REDNESS)	General disorders	—	—
Pyrexia (FEVER)	General disorders	—	—
Injection site swelling (SWELLING)	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Otitis media	Infections and infestations	—	—
Teething	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Otitis media acute	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Conjunctivitis	Infections and infestations	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Bronchiolitis	Infections and infestations	—	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Viral infection	Infections and infestations	—	—
Vomiting	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Gastroenteritis viral	Infections and infestations	—	—
Respiratory tract infection viral	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—
Candida infection	Infections and infestations	—	—
Candida nappy rash	Infections and infestations	—	—
Skin candida	Infections and infestations	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Plagiocephaly	Congenital, familial and genetic disorders	—	—
Ear infection	Infections and infestations	—	—
Acquired plagiocephaly	Musculoskeletal and connective tissue disorders	—	—
Agitation neonatal	Nervous system disorders	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—
Croup infectious	Infections and infestations	—	—

Most-reported serious reactions: Anaemia, Bronchiolitis, Bronchitis viral, Croup infectious, Gastroenteritis, Meningitis viral, Parainfluenzae virus infection, Pneumonia.

Data from ClinicalTrials.gov NCT03512288 adverse events section.

Sponsor's own description

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Publications & conference data

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

Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States.
Senders S, Klein NP, Lamberth E, Thompson A, et al · · 2021 · cited 46× · PMID 34525007 · DOI 10.1097/inf.0000000000003277
Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine Versus a 13-Valent Vaccine in Infants: A Systematic Review and Meta-Analysis.
Pacheco-Haro MD, de Arenas-Arroyo SN, Díaz-Goñi V, Velasco-Lucio EJ, et al · · 2025 · PMID 41295529 · DOI 10.3390/vaccines13111156

Verify or expand the search:

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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 NCT03512288 (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: 2 March 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/NCT03512288.

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

NCT03512288

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 (18 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Multivalent

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