Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

PT Bio Farma

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Biological: DTP/HB/Hib Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986335

Penta 0312

Details and patient eligibility

About

The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.

Full description

This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.

Enrollment: 600 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 weighting 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 1 month 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: Double Blind

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600 participants in 3 patient groups

DTP/HB/Hib Vaccine (Batch: A)

Experimental group

Description:

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/Hib vaccine (Batch: B)

Experimental group

Description:

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/Hib vaccine (Batch: C)

Experimental group

Description:

Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal

Treatment:

Biological: DTP/HB/Hib Vaccine