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Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV

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ClinicalTrials.gov Identifier: NCT03310073
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

Brief Summary:
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit

Condition or disease Intervention/treatment Phase
Healthy Biological: bOPV Biological: Pentabio Biological: IPV Phase 4

Detailed Description:
To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants
Actual Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: bOPV (bivalent OPV Bio Farma)

bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.

The subject received bOPV, Pentabio and IPV according to the study schedule.

Biological: bOPV
Batch Number: 2042015
Other Name: bivalent Oral Polio Vaccine

Biological: Pentabio
Batch number: 5050115 The vaccine shall be given intramuscularly.
Other Name: DTP-HB-Hib Vaccine

Biological: IPV
The vaccine shall be given intramuscularly.




Primary Outcome Measures :
  1. Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3 [ Time Frame: 30 days after the last vaccination ]
    Evaluate protectivity


Secondary Outcome Measures :
  1. Percentage of infants with increasing antibody titer >= 4 times [ Time Frame: 30 days after the last vaccination ]
    Serological response after four doses of bOPV with 1 dose of IPV

  2. Percentage of infants with transition of seronegative to seropositive [ Time Frame: 30 days after the last vaccination ]
    Serological response after four doses of bOPV with 1 dose of IPV

  3. Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV [ Time Frame: 30 days after the last vaccination ]
    Geometric Mean Titer (GMT) 30 days after the last vaccination

  4. Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV [ Time Frame: first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination. ]
    Assess the safety of bOPV

  5. Number of serious adverse events (SAE) which occured during the study [ Time Frame: 30 days after the last vaccination ]
    Assess the safety of bOPV



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, full term, newborns infants.
  • Newborns residing within a relatively short and easily accessible distance (<30 km) from the study clinic(s) and not planning to travel away during the entire study period.
  • Infant born after 37 weeks of pregnancy
  • Infant weighing 2.5 kg or more at birth (Birth weight > 2.5 kg)
  • Healthy newborns, with no history of asphyxia or meconium aspiration.
  • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
  • Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
  • Mother at least elementary school graduate

Exclusion Criteria:

  • Child concomitantly enrolled or scheduled to be enrolled in another trial
  • Known history of congenital or acquired immunodeficiency (including HIV infection)
  • Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C )
  • Newborns requiring hospitalization at birth.
  • Infant immunized with non-scheduled bOPV or IPV during trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310073


Locations
Indonesia
Hasan Sadikin Hospital
Bandung, West Java, Indonesia, 40161
Sponsors and Collaborators
PT Bio Farma
Investigators
Principal Investigator: Kusnandi Rusmil Hasan Sadikin Hospital

Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT03310073     History of Changes
Other Study ID Numbers: bOPV 0416
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs