Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

NCT00290342 | Completed Phase 3 Results

• 1 other identifier: 104871
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 9

Brief Summary

DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Tetanus; Acellular Pertussis; Diphtheria

Outcome Measures

Primary Outcomes (4)

• Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)

  A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).

  One month (Month 5) post-primary vaccination course

• Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3

  A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.

  One month (Month 5) post-primary vaccination course

• Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)

  Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.

  One month (Month 5) post-primary vaccination course

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

  Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations \< 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).

  One month (Month 5) post-primary vaccination course

Secondary Outcomes (8)

• Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)

  Before (Pre) and one month after (Post) the primary vaccination course

• Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)

  Before (Pre) and one month after (Post) the primary vaccination course

• Titers for Poliovirus Type 1, 2 and 3 Antibodies

  Before (Pre) and one month after (Post) the primary vaccination course

• Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)

  Before (Pre) and one month after (Post) the primary vaccination course

• Number of Subjects Reporting Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period, across doses

Study Arms (2)

Infanrix-IPV Group

EXPERIMENTAL

Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.

Biological: DTPa-IPV

Infanrix + IMOVAX Polio Group

ACTIVE COMPARATOR

Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Biological: DTPa; Biological: IMOVAX Polio®

Interventions

DTPa-IPV BIOLOGICAL

3 intramuscular injections

Also known as: Infanrix™-IPV

Infanrix-IPV Group

DTPa BIOLOGICAL

3 intramuscular injections

Also known as: Infanrix™

Infanrix + IMOVAX Polio Group

IMOVAX Polio® BIOLOGICAL

3 intramuscular injections

Infanrix + IMOVAX Polio Group

Eligibility Criteria

• Age: 8 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
• A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
• Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.
• History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
• Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
• Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Bucheon-si, 420-767, South Korea

Location

GSK Investigational Site

Daegu, 700-712, South Korea

Location

GSK Investigational Site

Gwangju, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Jeonju, 561-712, South Korea

Location

GSK Investigational Site

Seoul, 130-702, South Korea

Location

GSK Investigational Site

Seoul, 139-707, South Korea

Location

GSK Investigational Site

Seoul, 150-719, South Korea

Location

GSK Investigational Site

Seoul, South Korea

Location

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

DTPa-HBV-IPV combined vaccine; Pentetic Acid; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

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: February 10, 2006
• First Posted: February 13, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 23, 2007
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (9)