Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine

PT Bio Farma

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Biological: DTP/HB and Hib vaccine; Biological: DTP/HB/Hib vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986322

Penta 0211

Details and patient eligibility

About

The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.

Full description

This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.

Enrollment: 220 patients

Sex: All

Ages: 6 to 11 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infant 6-11 week of age
• Infant born after 37-42 week of pregnancy
• Infant weighing more than 2.5 kg at birth
• Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
• Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
• Mother at least graduate from elementary school
• Received Hepatitis B vaccine (Bio Farma) at birth

Exclusion criteria

• Child concomitantly enroll or schedule to be enroll in another trial
• Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
• Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
• History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
• Known history of congenital or acquired immunodeficiency (including HIV infection)
• Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 weeks)
• Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
• Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

DTP/HB/Hib vaccine

Experimental group

Description:

Group A will receive DTP/HB/Hib combination vaccine at 6-11, 10-15 and 14-19 weeks of age. DTP/HB/Hib component: Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal

Treatment:

Biological: DTP/HB/Hib vaccine

DTP/HB and Hib vaccine

Active Comparator group

Description:

Group B will receive DTP/HB and Hib Vaccines separately at 6-11,10-15, 14-19 weeks of age DTP/HB component: Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis rHbsAg Aluminum phosphate Natrium Chloride Thimerosal Hib component: Purified Haemophilus influenzae type b polysaccharide 10 mcg

Treatment:

Biological: DTP/HB and Hib vaccine