Table 1 Inclusion and exclusion criteria

From: Immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine, a systematic review and meta-analysis

 

KQ

Inclusion

Exclusion

Population

KQ1

Children and adolescents up to age 17

No limitations

KQ2

Adults aged 18 years or older

Participants from any setting in any geographical location

KQ1, KQ2

Subgroups:

 

Age groups

Sex*

Healthy participants

Participants with chronic medical conditions (e.g. chronic lung disease [asthma, COPD], chronic heart disease, diabetes) and immunosuppression

Vaccination status (vaccine-naïve participants, participants previously immunised with any pneumococcal vaccine)

Interventions

KQ1, KQ2

Vaccination with PCV15 authorised by the EMA and the FDA

Other pneumococcal vaccines

Alone or Sequential scheme with PPSV23

Control intervention

KQ1, KQ2

No vaccination

 

Placebo (containing no active product, another non-pneumococcal vaccine)

Vaccination with any other approved pneumococcal vaccine alone or sequentially

Outcomes

KQ1, KQ2

Efficacy and effectiveness:

Studies that do not include at least one of the outcomes listed under the inclusion criteria

Incidence of pneumococcal infection–related death,

Incidence of IPD, Incidence of pneumonia,

Incidence of pneumococcal infection–related hospitalisation

KQ2

Incidence of otitis media

 

KQ1, KQ2

Duration of protection for the vaccine effectiveness outcomes, Proportion of patients colonised with Streptococcus pneumoniae

 

KQ1, KQ2

Immunogenicity:

 

Adults and children:

 

OPA GMT, GMR

 

OPA Response: Proportion of participants with a ≥ 4-fold increase in OPA titres *

 

IgG Response: Proportion of patients with an IgG concentration of ≥0.35 µg/mL *

 

Children:

 

IgG GMC, GMR *

 

KQ1, KQ2

Safety:

 

Any adverse events (overall * and vaccine-related)

 

Local reactions (overall * and vaccine-related)

 

Systemic reactions (overall * and vaccine-related)

 

Any serious adverse events

 

Study design

 

RCT (Phase 2 or 3)

Cross-sectional studies, before-and-after studies

NRSI

Prospective and retrospective cohort studies with a control group

Case reports and case series

Case-control studies

Laboratory and animal studies

Publication type

 

Any peer-reviewed publication reporting primary data

Abstracts, letters

Pre-prints

Publications not reporting primary data (e.g. protocols), reviews, thesis, editorials

  1. COPD chronic obstructive pulmonary disease, EMA European Medicines Agency, FDA Food and Drug Administration, GMC geometric mean concentration, GMR geometric mean ratio, GMT geometric mean titres, IgG immunoglobulin G, IPD invasive pneumococcal disease, KQ key question, NRSI non-randomised studies of an intervention, OPA opsonophagocytic activity, PCV15 15-valent. pneumococcal conjugate vaccine, PPSV23 23-valent pneumococcal polysaccharide vaccine, RCT randomised controlled trial.
  2. *Amended after protocol submission.
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