Evidence map›Paper›PMID 20427630›Full record

Trial reportClinical and vaccine immunology : CVI2010

Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine compared to those of a 7-valent pneumococcal conjugate vaccine given as a three-dose series with routine vaccines in healthy infants and toddlers.

Susanna Esposito, Susan Tansey, Allison Thompson, Ahmad Razmpour, John Liang, Thomas R Jones, Giuseppe Ferrera, Alessandro Maida, Gianni Bona, Caterina Sabatini and 5 more

Open access · diamondAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
14.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 144 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 3 countries.

Susanna EspositoDepartment of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Susan Tansey
Allison Thompson
Ahmad Razmpour
John Liang
Thomas R Jones
Giuseppe Ferrera
Alessandro Maida
Gianni Bona
Caterina Sabatini
Lorenza Pugni
Emilio A Emini
William C Gruber
Daniel A Scott
Nicola Principi
Pfizer (United States) · USUniversity of Ragusa · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITUniversity of Milan · ITPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A 13-valent pneumococcal conjugate vaccine (PCV13) has been developed to improve protection against pneumococcal disease beyond that possible with the licensed 7-valent vaccine (PCV7). This study compared the safety and immunogenicity of PCV13 with those of PCV7 when given as part of the pediatric vaccination schedule recommended in Italy. A total of 606 subjects were randomly assigned to receive either PCV13 or PCV7 at 3, 5, and 11 months of age; all subjects concomitantly received diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B (DTaP-HBV-IPV/Hib) vaccine. Vaccine reactions were monitored. Antibody responses to DTaP-HBV-IPV/Hib antigens, serotype-specific anticapsular polysaccharide IgG responses, and antipneumococcal opsonophagocytic assay (OPA) activity were measured 1 month after the two-dose primary series and 1 month after the toddler dose. Overall, the safety profile of PCV13 was similar to that of PCV7. The response to DTaP-HBV-IPV/Hib antigens was substantially the same with both PCV13 and PCV7. PCV13 elicited antipneumococcal capsular IgG antibodies to all 13 vaccine serotypes, with notable increases in concentrations seen after the toddler dose. Despite a lower immunogenicity for serotypes 6B and 23F after the primary series of PCV13, responses to the seven common serotypes were comparable between the PCV13 and PCV7 groups when measured after the toddler dose. PCV13 also elicited substantial levels of OPA activity against all 13 serotypes following both the infant series and the toddler dose. In conclusion, PCV13 appeared comparable to PCV7 in safety profile and immunogenicity for common serotypes, demonstrated functional OPA responses for all 13 serotypes, and did not interfere with immune responses to concomitantly administered DTaP-HBV-IPV/Hib vaccine.

Indexed as

Pneumococcal VaccinesVaccines, ConjugateAntibodies, BacterialAntibodies, ViralDiphtheria-Tetanus-Pertussis VaccineDouble-Blind MethodFemaleHaemophilus VaccinesHepatitis B VaccinesHeptavalent Pneumococcal Conjugate VaccineHumansImmunization ScheduleImmunoglobulin GInfantItalyMale13-valent pneumococcal vaccineAntibodies, BacterialAntibodies, Viraldiphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccineDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesHepatitis B VaccinesHeptavalent Pneumococcal Conjugate VaccineImmunoglobulin GPneumococcal VaccinesPoliovirus Vaccine, InactivatedVaccines, CombinedVaccines, Conjugate

Identifiers

PMID20427630
PMCPMC2884425
OpenAlexW2140370976

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.