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Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland.
J Pediatric Infect Dis Soc 2016; 5(3):237-248JP

Abstract

After administering the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D-conjugated vaccine (PHiD-CV) to children aged 2-18 months, we observed a reduction in vaccine-type nasopharyngeal carriage, resulting in a reduction of overall pneumococcal nasopharyngeal carriage, which may be important for indirect vaccine effects. We noted a trend toward reduction of acute otitis media.

BACKGROUND

This trial (ClinicalTrials.gov identifier NCT00839254), nested within a cluster-randomized double-blind invasive pneumococcal disease effectiveness study in Finland (ClinicalTrials.gov identifier NCT00861380), assessed the effectiveness of the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D-conjugated vaccine (PHiD-CV or PCV10) against bacterial nasopharyngeal carriage and acute otitis media (AOM).

METHODS

Infants (aged 6 weeks to 6 months) received the PHiD-CV or a control vaccine (hepatitis B) (schedule 3+1 or 2+1). Nasopharyngeal swabs were collected at 4 time points post-vaccination from all of the infants and at pre-vaccination from a subset. Parent-reported physician-diagnosed AOM was assessed from first vaccination until last contact (mean follow-up, 18 months). Vaccine effectiveness (VE) was derived as (1 - relative risk)*100, accounting for cluster design in AOM analysis. Significant VE was assessed descriptively (positive lower limit of the non-adjusted 95% confidence interval [CI]).

RESULTS

The vaccinated cohort included 5093 infants for carriage assessment and 4117 infants for AOM assessment. Both schedules decreased vaccine-serotype carriage, with a trend toward a lesser effect from the 2+1 schedule (VE across timpoints 19%-56% [3+1] and 1%-38% [2+1]). Trends toward reduced pneumococcal carriage (predominantly vaccine serotypes 6B, 14, 19F, and 23F), decreased carriage of vaccine-related serotype 19A, and small increases at later time points (ages 14-15 months) in non-vaccine-serotype carriage were observed. No effects on nontypeable Haemophilus influenzae, Staphylococcus aureus, or Moraxella catarrhalis carriage were observed. There were non-significant trends toward a reduction in the number of infants reporting AOM episodes (VE 3+1: 6.1% [95% CI, -2.7% to 14.1%] and 2+1: 7.4% [-2.8% to 16.6%]) and all AOM episodes (VE 3+1: 2.8% [-9.5% to 13.9%] and 2+1: 10.2% [-4.1% to 22.9%]). PHiD-CV was immunogenic and had an acceptable safety profile.

CONCLUSIONS

We observed reduced vaccine-type pneumococcal carriage, a limited increase in non-vaccine-type carriage, and a trend toward AOM reduction.

Authors+Show Affiliations

Vaccine Research Centre , University of Tampere Medical School.Vaccine Research Centre , University of Tampere Medical School.Vaccine Research Centre , University of Tampere Medical School.National Institute for Health and Welfare , Oulu.GSK, Espoo , Finland.GSK, Espoo , Finland.GSK Vaccines, Wavre , Belgium.GSK Vaccines, Wavre , Belgium.GSK Vaccines, Wavre , Belgium.GSK Vaccines, Wavre , Belgium.GSK Vaccines, Wavre , Belgium.GSK Vaccines, Wavre , Belgium.GSK Vaccines, Wavre , Belgium.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27125273

Citation

Vesikari, Timo, et al. "Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus Influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland." Journal of the Pediatric Infectious Diseases Society, vol. 5, no. 3, 2016, pp. 237-248.
Vesikari T, Forsten A, Seppä I, et al. Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. J Pediatric Infect Dis Soc. 2016;5(3):237-248.
Vesikari, T., Forsten, A., Seppä, I., Kaijalainen, T., Puumalainen, T., Soininen, A., ... Schuerman, L. (2016). Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. Journal of the Pediatric Infectious Diseases Society, 5(3), pp. 237-248. doi:10.1093/jpids/piw010.
Vesikari T, et al. Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus Influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. J Pediatric Infect Dis Soc. 2016;5(3):237-248. PubMed PMID: 27125273.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. AU - Vesikari,Timo, AU - Forsten,Aino, AU - Seppä,Ilkka, AU - Kaijalainen,Tarja, AU - Puumalainen,Taneli, AU - Soininen,Anu, AU - Traskine,Magali, AU - Lommel,Patricia, AU - Schoonbroodt,Sonia, AU - Hezareh,Marjan, AU - Moreira,Marta, AU - Borys,Dorota, AU - Schuerman,Lode, Y1 - 2016/04/28/ PY - 2015/04/13/received PY - 2016/02/16/accepted PY - 2016/4/30/entrez PY - 2016/4/30/pubmed PY - 2018/4/20/medline KW - PHiD-CV KW - Streptococcus pneumoniae KW - acute otitis media KW - nasopharyngeal carriage KW - pneumococcal conjugate vaccine SP - 237 EP - 248 JF - Journal of the Pediatric Infectious Diseases Society JO - J Pediatric Infect Dis Soc VL - 5 IS - 3 N2 - UNLABELLED: After administering the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D-conjugated vaccine (PHiD-CV) to children aged 2-18 months, we observed a reduction in vaccine-type nasopharyngeal carriage, resulting in a reduction of overall pneumococcal nasopharyngeal carriage, which may be important for indirect vaccine effects. We noted a trend toward reduction of acute otitis media. BACKGROUND: This trial (ClinicalTrials.gov identifier NCT00839254), nested within a cluster-randomized double-blind invasive pneumococcal disease effectiveness study in Finland (ClinicalTrials.gov identifier NCT00861380), assessed the effectiveness of the 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D-conjugated vaccine (PHiD-CV or PCV10) against bacterial nasopharyngeal carriage and acute otitis media (AOM). METHODS: Infants (aged 6 weeks to 6 months) received the PHiD-CV or a control vaccine (hepatitis B) (schedule 3+1 or 2+1). Nasopharyngeal swabs were collected at 4 time points post-vaccination from all of the infants and at pre-vaccination from a subset. Parent-reported physician-diagnosed AOM was assessed from first vaccination until last contact (mean follow-up, 18 months). Vaccine effectiveness (VE) was derived as (1 - relative risk)*100, accounting for cluster design in AOM analysis. Significant VE was assessed descriptively (positive lower limit of the non-adjusted 95% confidence interval [CI]). RESULTS: The vaccinated cohort included 5093 infants for carriage assessment and 4117 infants for AOM assessment. Both schedules decreased vaccine-serotype carriage, with a trend toward a lesser effect from the 2+1 schedule (VE across timpoints 19%-56% [3+1] and 1%-38% [2+1]). Trends toward reduced pneumococcal carriage (predominantly vaccine serotypes 6B, 14, 19F, and 23F), decreased carriage of vaccine-related serotype 19A, and small increases at later time points (ages 14-15 months) in non-vaccine-serotype carriage were observed. No effects on nontypeable Haemophilus influenzae, Staphylococcus aureus, or Moraxella catarrhalis carriage were observed. There were non-significant trends toward a reduction in the number of infants reporting AOM episodes (VE 3+1: 6.1% [95% CI, -2.7% to 14.1%] and 2+1: 7.4% [-2.8% to 16.6%]) and all AOM episodes (VE 3+1: 2.8% [-9.5% to 13.9%] and 2+1: 10.2% [-4.1% to 22.9%]). PHiD-CV was immunogenic and had an acceptable safety profile. CONCLUSIONS: We observed reduced vaccine-type pneumococcal carriage, a limited increase in non-vaccine-type carriage, and a trend toward AOM reduction. SN - 2048-7207 UR - https://www.unboundmedicine.com/medline/citation/27125273/Effectiveness_of_the_10_Valent_Pneumococcal_Nontypeable_Haemophilus_influenzae_Protein_D_Conjugated_Vaccine__PHiD_CV__Against_Carriage_and_Acute_Otitis_Media_A_Double_Blind_Randomized_Clinical_Trial_in_Finland_ L2 - https://academic.oup.com/jpids/article-lookup/doi/10.1093/jpids/piw010 DB - PRIME DP - Unbound Medicine ER -