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

NCT00412854 | Completed Phase 3 Results

• 1 other identifier: 104567
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 2

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.

Conditions

Tetanus; Diphtheria; Acellular Pertussis

Outcome Measures

Primary Outcomes (3)

• Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)

  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).

  At Month 3

• Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)

  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).

  At Month 3

• Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies

  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.

  At Month 3

Secondary Outcomes (8)

• Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL

  At Month 3

• Concentrations for Anti-D and Anti-T Antibodies

  At Month 0 and Month 3

• Concentrations for Anti-PRP Antibodies

  At Month 0 and Month 3

• Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies

  At Month 3

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses

Interventions

Infanrix™/Hib BIOLOGICAL

Infanrix BIOLOGICAL

Hiberix BIOLOGICAL

Eligibility Criteria

• Age: 90 Days - 120 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Mengshan, China

Location

GSK Investigational Site

Wuzhou, China

Location

Related Publications (1)

• Yan-Ping Li, Shumin Zhang, Qiang Ye, Qiming Hou, Yanan Li, Hong Li, Yinghua Xu, Xiao Ma, Youping Liu, Xiaoling Chen, Lirong Huang, Gunasekaran Ramakrishnan, Richard Zhao, Haiwen Tang, Olivier Van Der Meeren, Hans L Bock.Combined diphtheria-tetanus-acellular pertussis vaccine mixed with Haemophilus influenzae type b conjugate vaccine is safe and immunogenic in two studies in Chinese infants.Chinese Journal of Vaccines - Zhongguo Yi Miao He Mian Yi (Zhongguo Ji Hua Mian Yi). Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Tetanus; Diphtheria

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; Hiberix

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Limitations and Caveats

None reported.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: January 3, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 25, 2007
• Last Updated: June 6, 2018
• Results First Posted: February 10, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)