Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type b; Diphtheria; Tetanus; Pertussis; Hepatitis B
• Interventions: Biological: Tritanrix-HepB/Hib; Biological: DTaP-IPV-HB-PRP~T

• Registration Number: NCT00313911
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.

To evaluate the overall safety in terms of:

Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.

Immunogenicity:

To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Study Start: 2006-07
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Results First Submitted: 2012-09-18
• Results First Submitted QC: 2012-10-18
• Results First Posted: 2012-11-19
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2133

Inclusion Criteria

• 2 months old infants on the day of inclusion
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
• Able to attend all scheduled visits and to comply with all trial procedures
• Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.

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 corticosteroids therapy
• Subjects with congenital or acquired immunodeficiency in the child's surrounding
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion
• Blood or blood-derived products received since birth
• Any vaccination in the 4 weeks preceding the first trial vaccination
• Vaccination planned in the 4 weeks following the trial vaccination
• Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
• Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
• Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
• Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
• History of seizures
• Febrile or acute illness on the day of inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Tritanrix-Hep B/Hib™+OPV	Tritanrix-HepB/Hib	-
Group 1: DTaP-IPV-Hep B-PRP-T	DTaP-IPV-HB-PRP~T	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.	Day 0 up to Day 7 post-injection	High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo	Day 30 post-dose 3	Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.; Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo	Day 30 post-dose 3	Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination	Day 0 up to Day 7 Post-injection	Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.; Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.