Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

NCT ID: NCT00254917

Last Updated: 2012-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2006-02-28

Brief Summary

The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.

WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.

To assess the safety of Pentaxim.

Detailed Description

Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:

Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.

Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.

All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.

Conditions

Diphtheria; Tetanus; Polio; Pertussis; Haemophilus Influenzae Type B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Concommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age

Group Type: EXPERIMENTAL

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

2

Concommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age.

Group Type: EXPERIMENTAL

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Interventions

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

Other Intervention Names

PENTAXIM™; PENTAXIM™

Eligibility Criteria

Inclusion Criteria

• Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
• Healthy male or female newborn
• Age ranging from birth to 48 hours of life (included)
• Birth weight >2.5 kg and gestational age >37 weeks
• Born to HBs antigen-negative mother

Exclusion Criteria

• Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
• Infant presently enrolled or scheduled to be enrolled in another clinical trial
• Infant with moderate or severe illness, mainly infectious diseases
• Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
• Infant with severe congenital defects or abnormalities
• Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• Known immunological deficiency (including a known HIV seropositive mother)
• Administration of vaccine since birth (other than BCG)
• Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 19 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Manila, , Philippines

Countries

Philippines

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

E2I29

Identifier Type: -

Identifier Source: org_study_id