NCT00533507 is a Phase 3 clinical trial of Synflorix in Infections, Rotavirus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00533507?

NCT00533507 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00533507?

Interventions in NCT00533507: Synflorix, Infanrix hexa, Rotarix.

What condition does NCT00533507 study?

NCT00533507 studies Infections, Rotavirus.

Is NCT00533507 still recruiting?

NCT00533507 is currently completed. Last updated 8 June 2018.

Are results published for NCT00533507?

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

Last reviewed 2018-06-08 · How we verify

NCT00533507

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

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

Completed Phase 3 Results posted Last updated 8 June 2018

What this trial tests

Phase 3 trial testing Synflorix in Infections, Rotavirus in 230 participants. Completed in 6 June 2008.

Timeline

18 September 2007

Primary endpoint
1 June 2008

6 June 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	230
Start date	18 September 2007
Primary completion	1 June 2008
Estimated completion	6 June 2008
Sites	3 locations across Taiwan

Drugs / interventions tested

Synflorix — full drug profile →
Infanrix hexa (infanrix-hexa) — full drug profile →
Rotarix — full drug profile →

Conditions studied

Infections, Rotavirus — all drugs for Infections, Rotavirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Weeks to 8 Weeks, any sex, with Infections, Rotavirus. 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.

Concentration of Anti-Protein D Antibodies Primary · One month after the third dose

Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Group	Value	95% CI
Synflorix Group	2277.6	2048.7 – 2532.1

Concentration of Anti-Pneumococcal Antibodies Primary · One month after the third dose

Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Anti-1

Group	Value	95% CI
Synflorix Group	2.92	2.65 – 3.22

Anti-4

Group	Value	95% CI
Synflorix Group	3.79	3.42 – 4.19

Anti-5

Group	Value	95% CI
Synflorix Group	4.50	4.11 – 4.93

Anti-6B

Group	Value	95% CI
Synflorix Group	1.69	1.47 – 1.94

Anti-7F

Group	Value	95% CI
Synflorix Group	4.07	3.72 – 4.46

Anti-9V

Group	Value	95% CI
Synflorix Group	3.90	3.51 – 4.32

Anti-14

Group	Value	95% CI
Synflorix Group	5.69	5.10 – 6.35

Anti-18C

Group	Value	95% CI
Synflorix Group	7.28	6.43 – 8.25

Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value Secondary · Before the first dose (pre) and one month after (post) the third dose

Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Pre (N=217)

Group	Value	95% CI
Synflorix Group	38

Post (N=219)

Group	Value	95% CI
Synflorix Group	218

Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value Secondary · Before the first dose (pre) and one month after (post) the third dose

Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Anti-1 Pre (N=217)

Group	Value	95% CI
Synflorix Group	111

Anti-1 Post (N=219)

Group	Value	95% CI
Synflorix Group	219

Anti-4 Pre (N=217)

Group	Value	95% CI
Synflorix Group	85

Anti-4 Post (N=219)

Group	Value	95% CI
Synflorix Group	219

Anti-5 Pre (N=217)

Group	Value	95% CI
Synflorix Group	149

Anti-5 Post (N=219)

Group	Value	95% CI
Synflorix Group	219

Anti-6B Pre (N=217)

Group	Value	95% CI
Synflorix Group	107

Anti-6B Post (N=219)

Group	Value	95% CI
Synflorix Group	215

Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value Secondary · One month after the third dose

Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

Anti-6A (N=219)

Group	Value	95% CI
Synflorix Group	210

Anti-19A (N=218)

Group	Value	95% CI
Synflorix Group	200

Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value Secondary · One month after the third dose

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.

Opsono-1 (N=102)

Group	Value	95% CI
Synflorix Group	98

Opsono-4 (N=103)

Group	Value	95% CI
Synflorix Group	103

Opsono-5 (N=102)

Group	Value	95% CI
Synflorix Group	101

Opsono-6B (N=102)

Group	Value	95% CI
Synflorix Group	89

Opsono-7F (N=103)

Group	Value	95% CI
Synflorix Group	103

Opsono-9V (N=98)

Group	Value	95% CI
Synflorix Group	98

Opsono-14 (N=102)

Group	Value	95% CI
Synflorix Group	101

Opsono-18C (N=101)

Group	Value	95% CI
Synflorix Group	99

Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value Secondary · One month after the third dose

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.

Opsono-6A

Group	Value	95% CI
Synflorix Group	87

Opsono-19A

Group	Value	95% CI
Synflorix Group	38

Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value Secondary · One month after the third dose

Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).

Group	Value	95% CI
Synflorix Group	58

Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value Secondary · One month after the third dose

Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).

Anti-diphteria toxoid

Group	Value	95% CI
Synflorix Group	58

Anti-tetanus toxoid

Group	Value	95% CI
Synflorix Group	58

Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value Secondary · One month after the third dose

Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Anti-PT (N=58)

Group	Value	95% CI
Synflorix Group	58

Anti-FHA (N=58)

Group	Value	95% CI
Synflorix Group	58

Anti-PRN (N=57)

Group	Value	95% CI
Synflorix Group	57

Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value Secondary · One month after the third dose

Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).

Group	Value	95% CI
Synflorix Group	32

Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value Secondary · One month after the third dose

Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.

Anti-poliovirus 1

Group	Value	95% CI
Synflorix Group	44

Anti-poliovirus 2

Group	Value	95% CI
Synflorix Group	44

Anti-poliovirus 3

Group	Value	95% CI
Synflorix Group	44

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Synflorix Group

Serious: 15

Deaths: —

Serious adverse events (15 terms)

Reaction	System	Synflorix Group
Urinary tract infection	Infections and infestations	—
Bronchiolitis	Infections and infestations	—
Gastroenteritis	Infections and infestations	—
Pyrexia	General disorders	—
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	—
Bronchopneumonia	Infections and infestations	—
Dehydration	Metabolism and nutrition disorders	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—
Enterocolitis	Gastrointestinal disorders	—
Gastroenteritis bacterial	Infections and infestations	—
Kawasaki's disease	Infections and infestations	—
Meningitis aseptic	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Vesicoureteric reflux	Renal and urinary disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	Synflorix Group
Irritability	General disorders	—
Drowsiness	General disorders	—
Loss of appetite	General disorders	—
Fever	General disorders	—
Pain	General disorders	—
Redness	General disorders	—
Swelling	General disorders	—
Vomiting	General disorders	—
Upper respiratory tract infection	Infections and infestations	—

Most-reported serious reactions: Urinary tract infection, Bronchiolitis, Gastroenteritis, Pyrexia, Bronchial hyperreactivity, Bronchopneumonia, Dehydration, Dermatitis atopic.

Data from ClinicalTrials.gov NCT00533507 adverse events section.

Sponsor's own description

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Synflorix

Trials testing the same drug.

NCT03896477 — Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants · Phase 3 · completed
NCT03197376 — Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants · Phase 3 · completed
NCT01735084 — Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life · Phase 4 · completed
NCT01204658 — Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants · Phase 2 · completed
NCT00547248 — Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines · Phase 3 · completed

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

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 NCT00533507 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 8 June 2018

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/NCT00533507.

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