Dagan 2001.

Methods	Randomised: yes, at individual level Design: standard parallel‐group design Intention‐to‐treat: no, per‐protocol analysis Follow‐up: 2 years starting 1 month after complete immunisation
Participants	N: 264 healthy infants (261 children were included in clinical follow‐up) Age: 12 to 35 months Setting: 8 day‐care centres in Beer‐Sheva, Israel Inclusion criteria: healthy children aged 12 to 35 months Exclusion criteria: children who had received any vaccine within the previous 4‐week period, or who were scheduled to receive any vaccine during the 4 weeks after the administration of the study vaccines, or who had received immunoglobulin within 8 weeks of study vaccination; known or suspected impairment of immunologic functions; major congenital malformation or serious chronic disease; known hypersensitivity to any components of the study vaccine; previous severe vaccine‐associated adverse reaction; previous vaccination with any pneumococcal or meningococcal vaccine; febrile illness (rectal temperature 38 °C) within 72 h before vaccination Baseline characteristics: described and balanced (Table 1 of trial publication)
Interventions	Children were randomly allocated to either CRM197‐PCV9 or MenC. Children aged 12 to 17 months at time of enrolment received 2 intramuscular injections 2 to 3 months apart, and those 18 to 35 months at time of enrolment received 1 intramuscular injection. Tx: CRM‐197‐PCV9; N = 131 C: MenC; N = 130 Additional vaccines: not described
Outcomes	Primary outcome: nasopharyngeal carriage of Streptococcus pneumoniae of the serotypes found in the vaccines in general and antibiotic‐resistant S pneumoniae in particular Secondary outcomes: parent‐reported respiratory infections including otitis media, tolerance (tenderness, local and systemic reactions after vaccination including erythema, induration, and fever) 18 encounters were planned for each child during the 2‐year follow‐up period. Encounters were planned to take place monthly during the first year and bimonthly during the second year. At each visit the parents were questioned about illness and antibiotic use since the last visit. Illness episodes were divided into 4 categories: (1) upper respiratory infections; (2) lower respiratory problems; (3) otitis media; and (4) other illnesses. Only episodes starting 1 month after complete immunisation were counted.
Funding sources	The study vaccines were provided by Wyeth‐Lederle Vaccines and Pediatrics (Pearl River, NY).
Declarations of interest	Not described
Notes	Participants lost to follow‐up during first 12 months:total: 32/261 (12.3%) Participants lost to follow‐up during first 12 months:Tx: 16/131 (12.2%) Participants lost to follow‐up during first 12 months:C: 16/130 (12.3%)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of random sequence generation not described. Block randomisation (n = 6) stratified by DCC and age.
Allocation concealment (selection bias)	Low risk	Randomisation list provided in a sealed envelope by Wyeth‐Lederle Vaccines.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	PCV9 and MenC vaccines dissimilar in appearance. 2 nurses not belonging to the study team injected the vaccines. They were not allowed to reveal the child's allocation.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Parental interview. A positive report of OM was defined as an episode.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up rates reported in Table 1. 12% of children followed up for < 12 months.
Selective reporting (reporting bias)	Unclear risk	Study protocol is not available.
Other bias	Low risk	No other sources of bias identified.