Clinical Trial: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women

Brief Summary: The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].

Detailed Summary:

The protocol was amended to include Spain in the study. The reasons for the Spain-specific amendment are listed below:

• Based on the feedback from the Spanish Ethics Committee, the evaluation related to the acceptance of cocooning was added in the protocol.
• The objectives and endpoints to include cocooning were added in the protocol.
• The eligibility criteria for participation of household contacts were defined in the protocol.
• The study procedures for household contacts were included.

Current Primary Outcome: Immunogenicity with respect to components of the study vaccine, in cord blood sample [ Time Frame: At delivery (anytime after 28 weeks of gestation) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Outcome of pregnancy in terms of pregnancy outcomes [ Time Frame: Up to Month 5 ]
  Pregnancy outcomes will include live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies
• Outcome of pregnancy in terms of listed pregnancy-related adverse events of interest/ neonate-related events of interest [ Time Frame: Up to Month 5 ]
  Listed pregnancy-related adverse events of interest/ neonate-related events of interest will include gestational diabetes, pregnancy-related hypertension, premature rupture of mem-branes, preterm premature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic encephalopathy and failure to thrive/growth deficiency
• Immunogenicity with respect to components of the study vaccine received during pregnancy [ Time Frame: One month post vaccination (Day 30) ]
  Anti-D, anti-T, anti-PT, anti-FHA and anti-PRN seroprotection/seropositivity status and antibody concentrations. - Vaccine response to PT, FHA and PRN. - Vaccine response to anti-D and anti-T
• Immunogenicity with respect to components of the study vaccine, in the cord blood sample [ Time Frame: At delivery (anytime after 28 weeks of gestation) ]
  Anti-PT, anti-FHA and anti-PRN seropositivity status
• Occurrence of solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-Day 7) follow-up period after each vaccination ]
  Occurrence of each solicited local/general symptoms
• Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccination ]
  Occurrence of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification (at Visit 1 and Visit 3)
• Occurrence of Serious adverse events (SAEs) [ Time Frame: From Day 0 up to Month 5 ]
  SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination
• Occurrence of SAEs among the vaccinated household contacts of the infants born to pregnant women in Spain, as part of an assessment of cocooning [ Time Frame: From Day 0 until post-delivery Month 2 (study end) ]
  SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination
• Percentage of household contacts of the infants born to pregnant women vaccinated in Spain [ Time Frame: From Day 0 until post-delivery Month 2 (study end) ]
  Contacts who accepted Boostrix vaccine as part of an as-sessment of cocooning among the eligible household contacts

Original Secondary Outcome:

• Outcome of pregnancy in terms of pregnancy outcomes [ Time Frame: Up to two months post-delivery approximately ]
  Pregnancy outcomes will include live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies
• Outcome of pregnancy in terms of pregnancy-related adverse events of interest/ neonate-related events [ Time Frame: Up to two months post-delivery approximately ]
  Pregnancy-related adverse events of interest/neonate-related events will include gestational diabetes, pregnancy-related hypertension, premature rupture of membranes, preterm pre-mature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic en-cephalopathy and failure to thrive/growth deficiency
• Immunogenicity with respect to components of the study vaccine received during pregnancy [ Time Frame: One month post vaccination (Day 30) ]
  Anti-D, anti-T, anti-PT, anti-FHA and anti-PRN seroprotection/seropositivity status and antibody concentrations. - Vaccine response to PT, FHA and PRN. - Vaccine response to anti-D and anti-T
• Immunogenicity with respect to components of the study vaccine, in the cord blood sample [ Time Frame: At delivery (anytime after 28 weeks of gestation) ]
  Anti-PT, anti-FHA and anti-PRN seropositivity status
• Occurrence of solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-Day 7) follow-up period after each vaccination ]
• Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccination ]
  Occurrence of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification (at Visit 1 and Visit 3)
• Occurrence of Serious adverse events (SAEs) [ Time Frame: From Day 0 up to two months post-delivery ]

Dates:
Date Received: February 26, 2015
Date Started: October 14, 2015
Date Completion: December 27, 2017
Last Updated: May 15, 2017
Last Verified: May 2017