Maternal Tdap Immunization in Guatemala
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|ClinicalTrials.gov Identifier: NCT02301702|
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pertussis Whooping Cough||Biological: Tdap Biological: Td||Phase 2|
The proposed study is a randomized, blinded, controlled, vaccine trial of maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36 weeks gestation). Pregnant women will be recruited from the prenatal care clinics at the Hospital Nacional de Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan Ostuncalco and Concepción Chiquirichapa.
All healthy pregnant women between the ages of 18 and 40 years (inclusive) at 27 weeks gestation or later who are in the study areas will be eligible to participate in this study unless they meet one or more of the exclusion criteria. Pregnant women at <27 weeks gestation will be pre-screened and provided information about the study to encourage them to enroll later in their pregnancy. Women who are eligible will be enrolled after obtaining informed consent, and then they will be randomized to receive Tdap vaccine or Td vaccine. Enrolled women and their infants will be followed up until 7 months postpartum.
To address the primary objective, serum specimens will be collected from mothers prior to receiving the study product (Tdap or Td), within 72 hours after delivery and at 7 months post-partum. Moreover, infants specimens will be collected at delivery (cord blood or infant blood within 72 hours of birth), at 2 months of age (prior to the first dose of the routine childhood DTwP series), and at 7 months of age (approximately 4 weeks after the third dose of the routine DTwP series).
Infants will be given all three doses of the pentavalent vaccine which includes DTwP vaccine at 2, 4 and 6 months (routine childhood immunizations) as recommended by the immunization schedule of Guatemala's National Immunization Program.
Adverse events and serious adverse events will also be monitored.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||286 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Tdap in Pregnancy to Prevent Infant Pertussis|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Tdap Vaccine
Combination Tetnus Toxoid, Reduced Diptheria Toxoid and Acellular Pertusis (Tdap)
Commercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Other Name: Boostrix, Adacel
Active Comparator: Td Vaccine
Tetanus toxoid and reduced diphtheria toxoid vaccine (Td)
The tetanus toxoid and reduced diphtheria toxoid vaccine (Td) used for this study will be the same preparation used by the National Immunization Program of Guatemala
- Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at birth (cord blood OR infant blood within 72 hours of birth), at 2 months of age, and 7 months of age [ Time Frame: Birth to 7 months of age ]
- Ratio of infant to mother pertussis antibody levels at the time of delivery [ Time Frame: Birth to 7 months of age ]
- Proportion of infants with at least a four-fold rise in serum antibody titer between 2 months and seven months of age (i.e., at four weeks after the 3rd dose of childhood DTwP) [ Time Frame: Birth to 7 months of age ]
- Maternal pertussis antibody GMC and 95% confidence intervals at baseline (pre-vaccination), within 72 hours after delivery, and seven months post-partum [ Time Frame: Pre-vaccination to 7 months post-partum ]
- Proportion of mothers sero-converting (serum pertussis antibody titer increase of ≥ 4-fold compared to pre-vaccination antibody levels) and 95% confidence intervals at the time of delivery (within 72 hours after delivery) and seven months post-partum [ Time Frame: Pre-vaccination to 7 months post-partum ]
- Incidence of illnesses meeting the syndromic case definition (defined below); prematurity; pneumonia (per WHO Integrated Management of Childhood Illness [IMCI] classification) [ Time Frame: Birth to 7 months of age ]
- Birth weight and infant growth/anthropometric measurements (e.g., height and weight for age). [ Time Frame: Birth to 7 months of age ]
- Incidence of unsolicited non-serious (grades 1 & 2) adverse events 7 days post-delivery (for neonates) [ Time Frame: Birth to 7 months of age ]
- Infant growth/anthropometric measurements (e.g., height and weight z-scores at birth and 7 months of age) [ Time Frame: Birth to 7 months of age ]
- Incidence of serious (grades 3 & 4) adverse events through 7 months of age [ Time Frame: Birth to 7 months of age ]
- Laboratory (real-time PCR) confirmed pertussis infection in infants younger than 6 months of age [ Time Frame: Birth to 7 months of age ]
- Incidence of unsolicited non-serious (grades 1&2) AEs 28 days post vaccination [ Time Frame: Pre-vaccination to 7 months post-partum ]
- Incidence of serious (grades 3 & 4) adverse events through 7 months post-partum [ Time Frame: Pre-vaccination to 7 months post-partum ]
- Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at 19 months after delivery [ Time Frame: Pre-vaccination to 19 mo post-partum ]
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): NCT02301702
|Universidad del Valle de Guatemala|
|Guatemala, Guatemala, 01015|
|Principal Investigator:||Saad B. Omer, MBBS,MPH,PhD||Emory University|