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

NCT03310073 | Completed Phase 4

• 1 other identifier: bOPV 0416
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3

  Evaluate protectivity

  30 days after the last vaccination

Secondary Outcomes (5)

• Percentage of infants with increasing antibody titer >= 4 times

  30 days after the last vaccination

• Percentage of infants with transition of seronegative to seropositive

  30 days after the last vaccination

• Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV

  30 days after the last vaccination

• Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV

  first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination.

• Number of serious adverse events (SAE) which occured during the study

  30 days after the last vaccination

Study Arms (1)

bOPV (bivalent OPV Bio Farma)

EXPERIMENTAL

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; Biological: Pentabio; Biological: IPV

Interventions

bOPV BIOLOGICAL

Batch Number: 2042015

Also known as: bivalent Oral Polio Vaccine

bOPV (bivalent OPV Bio Farma)

Pentabio BIOLOGICAL

Batch number: 5050115 The vaccine shall be given intramuscularly.

Also known as: DTP-HB-Hib Vaccine

bOPV (bivalent OPV Bio Farma)

IPV BIOLOGICAL

The vaccine shall be given intramuscularly.

bOPV (bivalent OPV Bio Farma)

Eligibility Criteria

• Age: 1 Minute - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

Study Officials

• Kusnandi Rusmil

  Hasan Sadikin General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: October 16, 2017
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

ID (1)