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

Hepatitis B Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343889
• Other study ID #: AL203
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2006
• Last updated: November 11, 2013
• Start date: August 2006
• Est. completion date: April 2008

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: April 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 50 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Hepatitis B
• Pertussis
• Tetanus

Intervention

Biological:
• DTaP-HB-PRP~T vaccine + OPV
0.5 mL, Intramuscular
• Tritanrix-HepB/Hib™ + OPV vaccine
0.5 mL, Intramuscular
• Oral Polio Vaccine
Oral co-administered with study vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 month post third vaccination	No
Secondary	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	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.	1 month post third vaccination	No
Secondary	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	Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).	1 month post third vaccination	No
Secondary	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	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.	1 month post third vaccination	No
Secondary	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	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.	1 month post third vaccination	No
Secondary	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	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.	Day 0 up to Day 7 after each vaccination	No

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