Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study

Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi: 10.1097/INF.0000000000001518.


Background: Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in children with sickle cell disease (SCD), who are at increased risk for infections.

Methods: In this phase III, open-label, single-center, controlled study in Burkina Faso (NCT01175083), children with SCD (S) or without SCD (NS) were assigned to 6 groups (N = 300): children 8-11 weeks of age (<6 months; <6S and <6NS groups) received 3 primary doses and a booster dose of PHiD-CV coadministered with routine childhood vaccines; children 7-11 months of age (7-11S and 7-11NS groups) received 2 primary doses and a booster dose of PHiD-CV; children 12-23 months of age (12-23S and 12-23NS groups) received 2 catch-up doses of PHiD-CV. Pneumococcal antibody responses were measured using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity. Responses to other antigens were measured by enzyme-linked immunosorbent assay. Adverse events were recorded.

Results: One month postprimary vaccination, for each vaccine serotype ≥98% of infants in the <6S and <6NS groups had antibody concentrations ≥0.2 µg/mL, except for 6B (≥85%) and 23F (≥89%). Immune responses to PHiD-CV after age-appropriate vaccination in children <2 years did not appear influenced by SCD. All infants were seroprotected/seropositive for diphtheria, tetanus and Bordetella pertussis antigens postprimary and booster vaccination. Safety and reactogenicity profiles were similar in children with or without SCD.

Conclusions: PHiD-CV was immunogenic with an acceptable safety profile in children with and without SCD starting vaccination at 8 weeks to 23 months of age.

Publication types

  • Clinical Trial, Phase III

MeSH terms

  • Age Factors
  • Anemia, Sickle Cell / immunology*
  • Anemia, Sickle Cell / pathology
  • Antibodies, Bacterial / biosynthesis*
  • Bacterial Proteins / chemistry
  • Bacterial Proteins / immunology
  • Carrier Proteins / chemistry
  • Carrier Proteins / immunology
  • Child, Preschool
  • Drug Administration Schedule
  • Female
  • Haemophilus Infections / immunology
  • Haemophilus Infections / pathology
  • Haemophilus Infections / prevention & control*
  • Haemophilus influenzae
  • Humans
  • Immunization, Secondary*
  • Immunogenicity, Vaccine*
  • Immunoglobulin D / chemistry
  • Immunoglobulin D / immunology
  • Infant
  • Lipoproteins / chemistry
  • Lipoproteins / immunology
  • Male
  • Patient Safety
  • Pneumococcal Vaccines / administration & dosage*
  • Pneumococcal Vaccines / biosynthesis
  • Pneumococcal Vaccines / immunology
  • Vaccination*
  • Vaccines, Conjugate
  • Vaccines, Subunit


  • Antibodies, Bacterial
  • Bacterial Proteins
  • Carrier Proteins
  • Immunoglobulin D
  • Lipoproteins
  • Pneumococcal Vaccines
  • Vaccines, Conjugate
  • Vaccines, Subunit
  • glpQ protein, Haemophilus influenzae