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Completed

NCT Number: NCT00343889

Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.

The primary objective is:

* To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

The secondary objectives are:

* To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and * To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Virus Diseases Whooping Cough

Age range

42 day–50 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Manila, Philippines

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
  • Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
  • Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
  • Chronic illness at a stage that could interfere with the conduct or completion of the trial
  • Blood or blood-derived products received since birth
  • HB vaccination since birth
  • Any vaccination in the four weeks preceding the first trial vaccination
  • Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
  • Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
  • History of seizures
  • Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Treatment and study plan

DTaP-HB-PRP~T vaccine + OPV

Biological

0.5 mL, Intramuscular

Tritanrix-HepB/Hib™ + OPV vaccine

Biological

0.5 mL, Intramuscular

Oral polio vaccine

Biological

Oral co-administered with study vaccine

Primary outcomes

  1. Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Time frame: 1 month post third vaccination

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.

    Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.

Secondary outcomes

  1. Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Time frame: 1 month post third vaccination

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.

    Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination.

  2. Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Time frame: 1 month post third vaccination

    Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).

  3. Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Time frame: 1 month post third vaccination

    Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.

    Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination.

  4. Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Time frame: 1 month post third vaccination

    Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).

    Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.

  5. Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

    Time frame: Day 0 up to Day 7 after each vaccination

    Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.

    Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 23, 2006
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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