Phase 2
N=301
Safety, Immunogenicity and Compatibility With DTP of a Typhoid Fever Vaccine in Infants
Typhoid Fever
Bottom Line
View on ClinicalTrials.gov: NCT00342628 ↗Enrolled (actual)
301
Serious AEs
0.7%
Results posted
Jun 2012
Primary outcome: Primary: Number of Infants With Adverse Reactions After Vaccination — 22; 24; 17; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vi-rEPA conjugate vaccine for typhoid fever (Biological); Hib-TT (Biological); DTP (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infants With Adverse Reactions After Vaccination |
22; 24; 17; 7; 7; 6 | — |
| SECONDARY IgG Anti-Vi Levels |
0.66; 0.55; 0.52; 17.42; 0.16; 0.05 | — |
| SECONDARY Antibody Responses to Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Toxin |
4.81; 3.92; 4.37; 4.18; 5.16; 4.03 | — |
| SECONDARY Antibody Responses to Hib CP |
2.11; 1.33; 2.0; 0.32; 8.35; 0.33 | — |
Summary
The purpose of this study is to evaluate the safety, immunogenicity, and compatibility of our Vi-rEPA conjugate administered to infants with their routine vaccinations.
We propose to recruit 300 full term healthy newborns in Vietnam and randomly divide them to receive Vi-rEPA plus DTP, Hib-TT (not yet used in Vietnam) plus DTP, or DTP alone. Consent is obtained following interviews of mothers during prenatal visits, or after delivery. All vaccines will be administered at 2, 4, and 6 months. A booster of Vi-rEPA or Hib-TT conjugate will be administered at 12 months of age and reactions monitored at 6, 24 and 48 hours after each injection. Maternal and cord blood samples are collected during labor and at delivery. Blood will be taken at 7, and 12 months of age from all study infants and at 13 months from infants injected with Vi-rEPA or with Hib-TT at 12 months. The blood samples will be assayed for Vi, Hib, diphtheria, tetanus and pertussis antibodies.
The levels of serum IgG anti-Vi elicited by Vi-rEPA administered to infants by the above schedule will be compared to those elicited by this vaccine in 2 to 5 year-olds in the efficacy trial conducted in Dong Thap Province, Vietnam.
Eligibility Criteria
Inclusion criteria
- Healthy full-term newborns.
- Birth weights of >=2500 grams.
Exclusion criteria
- Newborns without maternal and cord blood samples
- Newborns born to mothers with serious medical problems.
Data sourced from ClinicalTrials.gov (NCT00342628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.