A Phase II, Randomized Study on an Investigational DTPw-HBV/Hib-MenAC Conjugate Vaccine Administered to Infants in Northern Ghana
2008

Study on a New Vaccine for Infants in Northern Ghana

Sample size: 280 publication 10 minutes Evidence: high

Author Information

Author(s): Hodgson Abraham, Forgor Abudulai Adams, Chandramohan Daniel, Reed Zarifah, Binka Fred, Bevilacqua Cornelia, Boutriau Dominique, Greenwood Brian

Primary Institution: Navrongo Health Research Centre, Ministry of Health, Navrongo, Ghana

Hypothesis

Does the DTPw-HBV/Hib-MenAC conjugate vaccine induce a sufficient immune response in infants compared to the standard DTPw-HBV/Hib vaccine?

Conclusion

The new vaccine was found to be non-inferior to the standard vaccine and effectively induced protective antibody levels against meningococcal disease in infants.

Supporting Evidence

  • 87.8% of infants in the study group had protective antibody levels after vaccination.
  • The new vaccine induced higher antibody levels compared to the control group.
  • Significantly more infants in the study group maintained protective antibody levels at 12 months.
  • Reactogenicity was similar between the new and control vaccines.
  • Safety data showed no serious adverse events related to vaccination.

Takeaway

A new vaccine for babies can help protect them from serious diseases like meningitis, and it works just as well as the old vaccine.

Methodology

This was a phase II, double-blind, randomized, controlled study where 280 infants received either the new vaccine or the standard vaccine at specified intervals.

Potential Biases

Potential bias in reporting adverse events and the reliance on parental reporting for health outcomes.

Limitations

The study was limited to a specific geographic area and may not be generalizable to other populations.

Participant Demographics

Infants aged 6 to 8 weeks, both male and female, with a birth weight ≥2 kg.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI [80.4–93.8]

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0002159

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