Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Influenza Clinical Trial

Official title:

Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348881
• Other study ID #: AL201
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: August 15, 2013
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2133
• Est. completion date: June 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 50 Days

Eligibility

Inclusion Criteria:

At Screening:

• 0 to 3 day old infants

• Born at full term of pregnancy (= 37 weeks) with a birth weight = 2.5 kg

• Apgar score = 7 at three minutes after birth

• Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

• Six weeks of age

• Received a dose of Hepatitis B (HB) in the first three days of life

• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

At Screening:

• Illness at a stage that could interfere with trial conduct or completion

• Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)

• Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)

• Acute illness on the day of screening.

At Screening and at Inclusion:

• Blood or blood-derived products received since birth

• Planned participation in another clinical trial during the present trial period

• Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)

• Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination

• Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

• Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)

• Participation in another clinical trial before the first trial vaccination

• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy

• 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

• Vaccination other than with the study vaccines planned in the 12 weeks following inclusion

• Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)

• 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Influenza
• Pertussis
• Tetanus

Intervention

Biological:
• DTaP-HB-PRP~T combined vaccine
0.5 mL, Intramuscular
• Tritanrix-HepB/Hib™ vaccine
0.5 mL, Intramuscular
• Oral poliomyelitis vaccine (OPV)
Oral co-administered with study vaccine.

Locations

Country	Name	City	State
Philippines	Filinvest	Corporate City

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 for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV	Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.; Seroprotection was defined as titers = 10 mIU/mL for anti-Hep Bs; = 0.15 µg/mL for anti-PRP; = 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.	1 month post third vaccination	No
Primary	Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.	Occurence of at least one high fever episode (= 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.	Day 0 to Day 7 post-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 was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.	1 month post third vaccination	No
Secondary	Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV	Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.; Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - = 5cm; Fever - rectal 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 to Day 7 after vaccination	No

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