A clinical trial to assess the immunogenicity and Safety of two different formulations of Haemophilus Influenzae Type-B Vaccine (SII HibPRO) of Serum Institute of India Limited in Indian Infants.

Phase 4

Completed

• Conditions: Prevention of H. influenzae type-B infection

• Registration Number: CTRI/2009/091/000616
• Lead Sponsor: Serum Institute of India Ltd

Brief Summary

The study is initiated after ethics committee approval from the respective study centers. Eligible subjects receive 0.5 ml of SII HibPRO vaccine of either formulation at 6, 10 and 14 weeks of age. The parents/legal guardians are informed to visit the study centre 1 month after each dose of study vaccine. At each visit, the subjects are physically examined and history is asked for adverse events (AE) and concomitants medications. 3 ml of blood is collected at baseline and at 1 month after the third dose. Serum samples will be tested for anti-PRP antibodies.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-23
• Last Update Posted: 2013-02-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

1. Normal healthy infants of age 6-8 weeks at the time of first vaccination 2) Parents of subject willing to give written informed consent 3) Free of obvious health problems as established by medical history and physical examination.

Exclusion Criteria

• 1. Infant subject participating in other clinical trial.
• 2. Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
• 3. Infant with history of allergy or systemic hypersensitivity.
• 4. Infant with any chronic illness.
• 5)Infant who received blood or blood derived products in the past.
• 6. Known history of a bleeding disorder 7) Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or making it unlikely the subject could complete the protocol 8) History of febrile illness is a temporary exclusion criterion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity- Long term seroprotection	On day 0 and 84.

Secondary Outcome Measures

Name	Time	Method
Safety: Occurrence of any solicited adverse reaction, unsolicited adverse event or any serious adverse event.Immunogenicity: Short term Seroprotection	Safety assessment on day 0, 28, 56 and 84.Immunogenicity assessment on day 0 and 84.

Trial Locations

Locations (3)

Cheluvamba Hospital, Mysore Medical College and Research Institute, Mysore; 🇮🇳 Mysore, KARNATAKA, India

Dr. D. Y. Patil Medical College, Pune; 🇮🇳 Pune, MAHARASHTRA, India

SBKS Medical College and Dhiraj General Hospital, Piparia, Varodara.; 🇮🇳 Hospital,, India

Cheluvamba Hospital, Mysore Medical College and Research Institute, Mysore

🇮🇳Mysore, KARNATAKA, India

Dr. KrishnaMurthy B

Principal investigator

8212520512

bkm6@rediffmail.com