PMID- 33175600
OWN - NLM
STAT- MEDLINE
DCOM- 20210705
LR  - 20210705
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 5
DP  - 2021 May 4
TI  - Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal 
      non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy 
      toddlers: results from a phase I, randomized trial.
PG  - 1463-1469
LID - 10.1080/21645515.2020.1810493 [doi]
AB  - As a stepping stone toward evaluation in infants, the safety and immunogenicity 
      of an investigational 12-valent pneumococcal non-typeable Haemophilus influenzae 
      protein D-conjugate vaccine (12vPHiD-CV) was assessed in toddlers. 12vPHiD-CV 
      contains CRM(197)-conjugated capsular polysaccharides of serotypes 6A and 19A in 
      addition to capsular polysaccharides of the 10 serotypes in PHiD-CV. In this 
      phase I, double-blind, multicenter study (NCT01485406) conducted in Germany, 61 
      healthy toddlers aged 12-23 months previously primed with three PHiD-CV doses 
      were randomized (1:1) to receive one dose of 12vPHiD-CV or PHiD-CV. Safety and 
      reactogenicity of 12vPHiD-CV were assessed in terms of occurrence of grade 3 
      vaccination-related solicited and unsolicited adverse events (AEs) and 
      vaccination-related serious AEs. Immune responses were evaluated 1 month 
      post-vaccination. Grade 3 solicited local AEs (all considered 
      vaccination-related) were reported for two (6.5%, redness) and three (9.7%, 
      swelling) toddlers in the 12vPHiD-CV group and one (3.4%, swelling) in the 
      PHiD-CV group. Grade 3 vaccination-related solicited general AEs were only 
      reported in the PHiD-CV group. No grade 3 unsolicited or serious AEs were 
      reported. For PHiD-CV serotypes, 100% of toddlers in both groups had antibody 
      concentrations >/=0.2 microg/mL 1 month post-vaccination, and antibody geometric mean 
      concentrations increased from pre-boosting. For serotypes 6A and 19A, antibody 
      responses tended to be higher in the 12vPHiD-CV than the PHiD-CV group. A single 
      dose of 12vPHiD-CV administered in toddlers was well tolerated and no safety 
      concerns were identified. Immune responses were comparable to those induced by 
      PHiD-CV when administered in toddlers previously primed with three doses of 
      PHiD-CV.
FAU - Horn, Michael
AU  - Horn M
AUID- ORCID: 0000-0002-4699-5969
AD  - Pediatric Office, Schonau Am Konigssee, Germany.
FAU - Behre, Ulrich
AU  - Behre U
AD  - Private Practice, Kehl, Germany.
FAU - Traskine, Magali
AU  - Traskine M
AD  - HPV, Hepatitis and Pneumococcal Vaccines, Clinical R&D, GSK, Wavre, Belgium.
FAU - Dobbelaere, Kurt
AU  - Dobbelaere K
AUID- ORCID: 0000-0002-5426-2626
AD  - HPV, Hepatitis and Pneumococcal Vaccines, Clinical R&D, GSK, Wavre, Belgium.
FAU - Borys, Dorota
AU  - Borys D
AUID- ORCID: 0000-0001-9704-8462
AD  - HPV, Hepatitis and Pneumococcal Vaccines, Clinical R&D, GSK, Wavre, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT01485406
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201111
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Antibodies, Bacterial
MH  - Child, Preschool
MH  - Germany
MH  - *Haemophilus influenzae
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Infant
MH  - *Pneumococcal Infections
MH  - Pneumococcal Vaccines
MH  - Vaccines, Conjugate
PMC - PMC8078718
OTO - NOTNLM
OT  - PHiD-CV
OT  - Pneumococcal conjugate vaccine
OT  - booster dose
OT  - immunogenicity
OT  - safety
OT  - toddlers
COIS- MT and DB are employed by the GSK group of companies. KD was employed by the GSK 
      group of companies. DB and KD hold shares in the GSK group of companies. MH 
      received a grant from the GSK group of companies for study conduct. UB has 
      nothing to disclose.
EDAT- 2020/11/12 06:00
MHDA- 2021/07/06 06:00
PMCR- 2020/11/11
CRDT- 2020/11/11 17:12
PHST- 2020/11/12 06:00 [pubmed]
PHST- 2021/07/06 06:00 [medline]
PHST- 2020/11/11 17:12 [entrez]
PHST- 2020/11/11 00:00 [pmc-release]
AID - 1810493 [pii]
AID - 10.1080/21645515.2020.1810493 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 May 4;17(5):1463-1469. doi: 
      10.1080/21645515.2020.1810493. Epub 2020 Nov 11.