NCT00696423 is a Phase 3 clinical trial of Infanrix™ in Acellular Pertussis, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00696423?

NCT00696423 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00696423?

Interventions in NCT00696423: Infanrix™, Hiberix™.

What condition does NCT00696423 study?

NCT00696423 studies Acellular Pertussis, Diphtheria, Tetanus.

Is NCT00696423 still recruiting?

NCT00696423 is currently completed. Last updated 6 June 2018.

Are results published for NCT00696423?

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

Last reviewed 2018-06-06 · How we verify

NCT00696423

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

Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

Completed Phase 3 Results posted Last updated 6 June 2018

What this trial tests

Phase 3 trial testing Infanrix™ in Acellular Pertussis in 467 participants. Completed in 26 July 2008.

Timeline

7 June 2008

Primary endpoint
26 July 2008

26 July 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	467
Start date	7 June 2008
Primary completion	26 July 2008
Estimated completion	26 July 2008
Sites	3 locations across China

Drugs / interventions tested

Infanrix™
Hiberix™

Conditions studied

Acellular Pertussis — all drugs for Acellular Pertussis →
Diphtheria — all drugs for Diphtheria →
Tetanus — all drugs for Tetanus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 Months to 24 Months, any sex, with Acellular Pertussis or Diphtheria. 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.

Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations Primary · One month after booster vaccination

Geometric mean concentrations are given in microgram per milliliter (μg/mL).

Group	Value	95% CI
Infanrix/Hib Single Injection Group	34.428	29.452 – 40.244
Infanrix + Hiberix Separate Injection Group	132.075	112.563 – 154.970

Anti-diphtheria Toxoid Antibody Concentrations Primary · One month after booster vaccination

Geometric mean concentrations are given in international Unit per milliliter (IU/mL).

Group	Value	95% CI
Infanrix/Hib Single Injection Group	0.945	0.905 – 0.987
Infanrix + Hiberix Separate Injection Group	0.926	0.887 – 0.966

Anti-tetanus Toxoid Antibody Concentrations Primary · One month after booster vaccination

Geometric mean concentrations are given in IU/mL.

Group	Value	95% CI
Infanrix/Hib Single Injection Group	7.455	6.881 – 8.077
Infanrix + Hiberix Separate Injection Group	10.104	9.080 – 11.242

Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations Primary · One month after booster vaccination

Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

Anti-PT

Group	Value	95% CI
Infanrix/Hib Single Injection Group	52.2	48.1 – 56.7
Infanrix + Hiberix Separate Injection Group	55.8	51.7 – 60.3

Anti-FHA

Group	Value	95% CI
Infanrix/Hib Single Injection Group	93.3	82.6 – 105.4
Infanrix + Hiberix Separate Injection Group	92.8	83.3 – 103.4

Anti-PRN

Group	Value	95% CI
Infanrix/Hib Single Injection Group	235.9	208.7 – 266.5
Infanrix + Hiberix Separate Injection Group	241.6	213.6 – 273.2

The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies Primary · One month after booster vaccination

Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.

Seroprotection against PRP (n=238, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	238
Infanrix + Hiberix Separate Injection Group	216

Seroprotection against diphtheria (n=237, 214)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	237
Infanrix + Hiberix Separate Injection Group	214

Seroprotection against tetanus (n=237, 214)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	237
Infanrix + Hiberix Separate Injection Group	214

Seropositivity for anti-PT (n=239, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	226
Infanrix + Hiberix Separate Injection Group	213

Seropositivity for anti-FHA (n=239, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	238
Infanrix + Hiberix Separate Injection Group	216

Seropositivity for anti-PRN (n=239, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	239
Infanrix + Hiberix Separate Injection Group	215

Anti-PRP Antibody Concentrations Secondary · Before booster vaccination

Geometric mean concentrations are given in μg/mL.

Group	Value	95% CI
Infanrix/Hib Single Injection Group	1.240	1.085 – 1.418
Infanrix + Hiberix Separate Injection Group	2.461	2.136 – 2.837

Anti-diphtheria Toxoid Antibody Concentrations Secondary · Before booster vaccination

Geometric mean concentrations are given in IU/mL.

Group	Value	95% CI
Infanrix/Hib Single Injection Group	0.055	0.053 – 0.058
Infanrix + Hiberix Separate Injection Group	0.054	0.052 – 0.057

Anti-tetanus Toxoid Antibody Concentrations Secondary · Before booster vaccination

Geometric mean concentrations are given in IU/mL.

Group	Value	95% CI
Infanrix/Hib Single Injection Group	0.219	0.195 – 0.247
Infanrix + Hiberix Separate Injection Group	0.311	0.274 – 0.353

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Secondary · Before booster vaccination

Geometric mean concentrations are given in EL.U/mL.

Anti-PT

Group	Value	95% CI
Infanrix/Hib Single Injection Group	10.0	10.0 – 10.0
Infanrix + Hiberix Separate Injection Group	10.0	10.0 – 10.1

Anti-FHA

Group	Value	95% CI
Infanrix/Hib Single Injection Group	10.1	10.0 – 10.2
Infanrix + Hiberix Separate Injection Group	10.3	9.9 – 10.7

Anti-PRN

Group	Value	95% CI
Infanrix/Hib Single Injection Group	10.2	10.0 – 10.4
Infanrix + Hiberix Separate Injection Group	10.3	10.0 – 10.5

The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies Secondary · Before booster vaccination

Seroprotection against PRP (n= 237, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	236
Infanrix + Hiberix Separate Injection Group	216

Seroprotection against diphtheria (n= 237, 214)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	21
Infanrix + Hiberix Separate Injection Group	16

Seroprotection against tetanus (n= 237, 214)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	209
Infanrix + Hiberix Separate Injection Group	198

Seropositivity for anti-PT (n= 239, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	0
Infanrix + Hiberix Separate Injection Group	1

Seropositivity for anti-FHA (n= 239, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	2
Infanrix + Hiberix Separate Injection Group	3

Seropositivity for anti-PRN (n= 239, 216)

Group	Value	95% CI
Infanrix/Hib Single Injection Group	3
Infanrix + Hiberix Separate Injection Group	4

Number of Subjects Reporting Solicited Local and General Symptoms Secondary · During the 4-day follow-up period after booster vaccination

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.

Pain

Group	Value	95% CI
Infanrix/Hib Single Injection Group	26
Infanrix + Hiberix Separate Injection Group	26

Redness

Group	Value	95% CI
Infanrix/Hib Single Injection Group	16
Infanrix + Hiberix Separate Injection Group	8

Swelling

Group	Value	95% CI
Infanrix/Hib Single Injection Group	9
Infanrix + Hiberix Separate Injection Group	1

Drowsiness

Group	Value	95% CI
Infanrix/Hib Single Injection Group	26
Infanrix + Hiberix Separate Injection Group	20

Fever

Group	Value	95% CI
Infanrix/Hib Single Injection Group	73
Infanrix + Hiberix Separate Injection Group	93

Irritability

Group	Value	95% CI
Infanrix/Hib Single Injection Group	43
Infanrix + Hiberix Separate Injection Group	46

Loss of appetite

Group	Value	95% CI
Infanrix/Hib Single Injection Group	40
Infanrix + Hiberix Separate Injection Group	39

Number of Subjects Reporting Unsolicited Adverse Events (AE) Secondary · During the 31-day follow-up period after booster vaccination

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Group	Value	95% CI
Infanrix/Hib Single Injection Group	66
Infanrix + Hiberix Separate Injection Group	56

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.

Infanrix/Hib Single Injection Group

Serious: 1

Deaths: —

Infanrix + Hiberix Separate Injection Group

Serious: 3

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Infanrix/Hib Single Inject…	Infanrix + Hiberix Separat…
Bronchopneumonia	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Infanrix/Hib Single Inject…	Infanrix + Hiberix Separat…
Fever	General disorders	—	—
Irritability	General disorders	—	—
Loss of appetite	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Pain at injection site	General disorders	—	—
Drowsiness	General disorders	—	—
Redness at injection site	General disorders	—	—

Most-reported serious reactions: Bronchopneumonia, Bronchitis.

Data from ClinicalTrials.gov NCT00696423 adverse events section.

Sponsor's own description

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.

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 Infanrix™

Trials testing the same drug.

NCT01171963 — Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants · Phase 3 · completed
NCT01000974 — Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants · Phase 3 · completed
NCT00197236 — Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccin · 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 NCT00696423 (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: 6 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/NCT00696423.

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

NCT00696423

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 (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Infanrix™

Other GlaxoSmithKline trials

Verify against primary sources