Evidence map›Paper›PMID 28319456›Full record

Trial reportHuman vaccines & immunotherapeutics2017

Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females.

Tao Haskins-Coulter, Jo Southern, Nick Andrews, Elizabeth Miller

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00956553 (A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 16% 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.

NCT00956553 phase4completednot on this map

A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines

TypeinterventionalSponsorPublic Health EnglandRan2009 to 2013Enrolled400ConditionsHPV InfectionsArmsCervarix, Gardasil
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
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

4 authors at 1 institution in 1 country.

Tao Haskins-Coultera Immunisation, Hepatitis and Blood Safety Department , Public Health England , London , UK.
Jo Southerna Immunisation, Hepatitis and Blood Safety Department , Public Health England , London , UK.
Nick Andrewsa Immunisation, Hepatitis and Blood Safety Department , Public Health England , London , UK.
Elizabeth Millera Immunisation, Hepatitis and Blood Safety Department , Public Health England , London , UK.
Public Health England · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

One hundred and ninety eight females aged 12-15 y were enrolled in an observer-blinded randomized trial to assess the immunogenicity and reactogenicity of the tetravalent HPV vaccine Gardasil® (group 2), in comparison to the bivalent HPV vaccine, Cervarix® (group 1), which was routinely offered in the national vaccination schedule at the time. Participants were blinded to treatment group until all 3 vaccinations had been given, while laboratory staff were masked during testing. For the majority of local and general reactions, recipients of both vaccines reported comparable frequencies. Local and systemic events were rarely of high severity, except for tenderness at the injection site which reached a severe level after at least one of the doses in 24% of the Cervarix® group and 7% of the Gardasil® group (p = 0.001 comparing groups). For most reactions, no dose response was recorded, except for swelling with higher reporting at dose 3 (17.7%) than dose 1 (3.1%) for Cervarix®. SAE reporting was low (n = 3) and considered unrelated to either vaccine. This paper supports the body of evidence that Gardasil® has an acceptable safety profile when compared with Cervarix® and other vaccines given in the national program.

Indexed as

AdolescentChildDrug-Related Side Effects and Adverse ReactionsFemaleHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansPapillomavirus VaccinesSingle-Blind MethodUnited KingdomHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18human papillomavirus vaccine, L1 type 16, 18Papillomavirus VaccinesCervarix®gardasil®Human Papillomavirus (HPV) vaccinereactogenicityvaccine safety

Identifiers

PMID28319456
PMCPMC5489300
OpenAlexW2598988437

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.