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Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage

Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01109108
Enrollment
9000
Registered
2010-04-22
Start date
2010-04-30
Completion date
2015-03-31
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carriage of S. Pneumoniae

Keywords

pneumococcal vaccine, nasopharyngeal carriage

Brief summary

The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children \< 5. Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.

Interventions

None listed

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Boston Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* children \< 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate

Exclusion criteria

* children with facial malformations making NP sampling unacceptable * children in foster care

Design outcomes

Primary

MeasureTime frameDescription
Nasopharngeal Colonization With PCV13 S. PneumoniaeStudy years 1-5Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae

Countries

United States

Participant flow

Recruitment details

Children aged 0\<60 months with non-toxic appearance presenting for well child or urgent care visit at urban hospital recruited from July 1, 2010 - March 27, 2015; each child could be enrolled only once per 60 day period.

Participants by arm

ArmCount
Children 0<2 Years of Age
Children 0\<2 years of age with and without concurrent respiratory tract infection
4,035
Children 2<5 Years of Age
Children 2\<5 years of age with and without concurrent respiratory tract infection
4,755
Total8,790

Baseline characteristics

CharacteristicChildren 0<2 Years of AgeChildren 2<5 Years of AgeTotal
Age, Categorical
<=18 years
4035 Participants4755 Participants8790 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous12.1 months
STANDARD_DEVIATION 5.7
40.0 months
STANDARD_DEVIATION 10.3
27.2 months
STANDARD_DEVIATION 16.3
Pneumococcal risk factors
Current daycare attendance
No
2818 Participants1868 Participants4686 Participants
Pneumococcal risk factors
Current daycare attendance
Yes
1217 Participants2887 Participants4104 Participants
Pneumococcal risk factors
Current RTI (Respiratory tract infection)
No
2196 Participants2647 Participants4843 Participants
Pneumococcal risk factors
Current RTI (Respiratory tract infection)
Yes
1839 Participants2108 Participants3947 Participants
Pneumococcal risk factors
Ever Breastfed
No
813 Participants1071 Participants1884 Participants
Pneumococcal risk factors
Ever Breastfed
Yes
3222 Participants3684 Participants6906 Participants
Pneumococcal risk factors
PCV13 Immune
No
795 Participants832 Participants1627 Participants
Pneumococcal risk factors
PCV13 Immune
Yes
3240 Participants3923 Participants7163 Participants
Pneumococcal risk factors
Recent antibiotic use (last 14 days)
No
3500 Participants4304 Participants7804 Participants
Pneumococcal risk factors
Recent antibiotic use (last 14 days)
Yes
535 Participants451 Participants986 Participants
Race (NIH/OMB)
American Indian or Alaska Native
7 Participants6 Participants13 Participants
Race (NIH/OMB)
Asian
123 Participants124 Participants247 Participants
Race (NIH/OMB)
Black or African American
2719 Participants3445 Participants6164 Participants
Race (NIH/OMB)
More than one race
739 Participants828 Participants1567 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
White
445 Participants351 Participants796 Participants
Region of Enrollment
United States
4035 participants4755 participants8790 participants
Sex: Female, Male
Female
1935 Participants2402 Participants4337 Participants
Sex: Female, Male
Male
2100 Participants2353 Participants4453 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 4,0350 / 4,755
other
Total, other adverse events
0 / 4,0350 / 4,755
serious
Total, serious adverse events
0 / 4,0350 / 4,755

Outcome results

Primary

Nasopharngeal Colonization With PCV13 S. Pneumoniae

Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae

Time frame: Study years 1-5

Population: Children colonized with any S. pneumoniae (PCV and non-PCV serotypes)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2010-2011PCV13 serotype20 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2010-2011Non-PCV13 serotype166 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2011-2012PCV13 serotype23 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2011-2012Non-PCV13 serotype306 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2012-2013PCV13 serotype6 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2012-2013Non-PCV13 serotype187 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2013-2014PCV13 serotype2 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2013-2014Non-PCV13 serotype108 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2014-2015PCV13 serotype0 Participants
Children 0<2 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2014-2015Non-PCV13 serotype64 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2013-2014Non-PCV13 serotype150 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2010-2011PCV13 serotype31 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2012-2013Non-PCV13 serotype239 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2010-2011Non-PCV13 serotype137 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2014-2015Non-PCV13 serotype92 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2011-2012PCV13 serotype11 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2013-2014PCV13 serotype5 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2011-2012Non-PCV13 serotype297 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2014-2015PCV13 serotype2 Participants
Children 2<5 Years of AgeNasopharngeal Colonization With PCV13 S. Pneumoniae2012-2013PCV13 serotype5 Participants
p-value: <0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026