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

Healthy Clinical Trial

Official title:

Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986322
• Other study ID #: Penta 0211
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2013
• Last updated: November 11, 2013
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2013
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 11 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• DTP/HB/Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly
• DTP/HB and Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly

Locations

Country	Name	City	State
Indonesia	Garuda Primary Health Center	Bandung	West Java
Indonesia	Ibrahim Adji Primary Health Care Center	Bandung	West Java
Indonesia	Puter Primary Health Center	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protectivity of DTP/HB/Hib (Bio Farma) vaccine	Percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHbs titer >=10mlIU/ml, and antiPRP-TT titer >= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group	4 months	No
Secondary	Antibody response to diphteria toxoid in both group	Serological response to diphteria toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=0.1 IU/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive.	4 months	No
Secondary	Antibody response to Tetanus Toxoid in both group	Serological response to tetanus toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=0.1 IU/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive	4 months	No
Secondary	Antibody response to Pertussis component in both group	Serological response to the pertussis component (agglutinins): GMT,percentage of infants with titre >=40, >=80,>=160 and >=320 (1/dil.), percentage of infants with increasing antibody titer >=4 times.	4 months	No
Secondary	Antibody response to Hepatitis B in both group	Serological response to Hepatitis B: Geometric mean of anti-HBs, percentage of infants with titer >=10mlIU/ml, percentage of infants with increasing antibody titer >=4 times and/ or percentage of infants with transition of seronegative to seropositive.	4 months	No
Secondary	Antibody response to PRP-T in both group	Serological response to Hib/PRP: GMT, percentage of infants with titre >=1ug/ml and >=0.15ug/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive	4 months	No
Secondary	Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)	Local and systemic reaction	30 minutes, 72 hours, 28 days after immunization	Yes