Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

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ClinicalTrials.gov Identifier: NCT00412854

Recruitment Status : Completed

First Posted : December 19, 2006

Results First Posted : February 10, 2017

Last Update Posted : June 6, 2018

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.

Condition or disease	Intervention/treatment	Phase
Tetanus Diphtheria Acellular Pertussis	Biological: Infanrix™/Hib Biological: Infanrix Biological: Hiberix	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	660 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.
Study Start Date :	January 3, 2007
Actual Primary Completion Date :	June 1, 2007
Actual Study Completion Date :	June 25, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Haemophilus Infections Vaccines

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Diphtheria

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) [ Time Frame: At Month 3 ]
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) [ Time Frame: At Month 3 ]
A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies [ Time Frame: At Month 3 ]
The vaccine response was defined as it follows:
- for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;
- for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.

Secondary Outcome Measures :

Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL [ Time Frame: At Month 3 ]
The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
Concentrations for Anti-D and Anti-T Antibodies [ Time Frame: At Month 0 and Month 3 ]
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
Concentrations for Anti-PRP Antibodies [ Time Frame: At Month 0 and Month 3 ]
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies [ Time Frame: At Month 3 ]
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses ]
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses ]
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period after each vaccination ]
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From receipt of first dose of study vaccine (Day 0) to study end (Month 3) ]
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

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Ages Eligible for Study:	90 Days to 120 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412854

Locations

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China
GSK Investigational Site
Mengshan, China
GSK Investigational Site
Wuzhou, China

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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