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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.

Abstract 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.
PMID
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Immunogenicity and Safety Of 10-Valent Pneumococcal Non-Typeable 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.

Authors

Mayor MeshTerms

Immunization, Secondary

Immunogenicity, Vaccine

Vaccination

Keywords
Journal Title the pediatric infectious disease journal
Publication Year Start




PMID- 28403055
OWN - NLM
STAT- MEDLINE
DA  - 20170413
DCOM- 20170420
LR  - 20170420
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 36
IP  - 5
DP  - 2017 May
TI  - 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.
PG  - e136-e150
LID - 10.1097/INF.0000000000001518 [doi]
AB  - 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 microg/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.
FAU - Sirima, Sodiomon B
AU  - Sirima SB
AD  - From the *Groupe de Recherche Action en Sante (GRAS), Ouagadougou, Burkina Faso; 
      daggerCentre National de Recherche et de Formation sur le Paludisme (CNRFP),
      Ouagadougou, Burkina Faso; double daggerCentre Hospitalier Universitaire Yalgado 
      Ouedraogo (CHUYO), Ouagadougou, Burkina Faso; section signGSK, Wavre, Belgium;
      and paragraph signXPE Pharma & Science C/O GSK, Wavre, Belgium.
FAU - Tiono, Alfred
AU  - Tiono A
FAU - Gansane, Zakaria
AU  - Gansane Z
FAU - Siribie, Mohamadou
AU  - Siribie M
FAU - Zongo, Angele
AU  - Zongo A
FAU - Ouedraogo, Alphonse
AU  - Ouedraogo A
FAU - Francois, Nancy
AU  - Francois N
FAU - Strezova, Ana
AU  - Strezova A
FAU - Dobbelaere, Kurt
AU  - Dobbelaere K
FAU - Borys, Dorota
AU  - Borys D
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Bacterial Proteins)
RN  - 0 (Carrier Proteins)
RN  - 0 (Immunoglobulin D)
RN  - 0 (Lipoproteins)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (Vaccines, Subunit)
RN  - EC 3.1.4.46 (glpQ protein, Haemophilus influenzae)
SB  - IM
MH  - Age Factors
MH  - Anemia, Sickle Cell/*immunology/pathology
MH  - Antibodies, Bacterial/*biosynthesis
MH  - Bacterial Proteins/chemistry/immunology
MH  - Carrier Proteins/chemistry/immunology
MH  - Child, Preschool
MH  - Drug Administration Schedule
MH  - Female
MH  - Haemophilus Infections/immunology/pathology/*prevention & control
MH  - Haemophilus influenzae
MH  - Humans
MH  - *Immunization, Secondary
MH  - *Immunogenicity, Vaccine
MH  - Immunoglobulin D/chemistry/immunology
MH  - Infant
MH  - Lipoproteins/chemistry/immunology
MH  - Male
MH  - Patient Safety
MH  - Pneumococcal Vaccines/*administration & dosage/biosynthesis/immunology
MH  - *Vaccination
MH  - Vaccines, Conjugate
MH  - Vaccines, Subunit
EDAT- 2017/04/14 06:00
MHDA- 2017/04/21 06:00
CRDT- 2017/04/14 06:00
AID - 10.1097/INF.0000000000001518 [doi]
AID - 00006454-201705000-00017 [pii]
PST - ppublish
SO  - Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi:
      10.1097/INF.0000000000001518.

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